- |||||||||| Gamunex (intravenous normal human immunoglobulin 10%) / Bayer, Grifols, Kedrion
Trial completion date, Trial primary completion date: Intravenous Gammaglobulin for Sickle Cell Pain Crises (clinicaltrials.gov) - Oct 21, 2024
P1/2, N=300, Recruiting,
Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Dec 2025 --> Dec 2026
- |||||||||| SYMMETRICAL DRUG-RELATED INTERTRIGINOUS AND FLEXURAL EXANTHEMA (SDRIFE) FOLLOWING FIRST ADMINISTRATION OF IMMUNOGLOBULIN REPLACEMENT (Monitor 2; Hall A) - Sep 29, 2024 - Abstract #ACAAI2024ACAAI_737;
Workup revealed decreased immunoglobulin G (IgG) of 466 mg/dl, absent titers to streptococcus pneumoniae and haemophilus influenza without improvement following Pneumovax challenge...Emergency room evaluation with Dermatology evaluation revealed normal blood counts and chemistries with elevated C-reactive protein suggestive of a diagnosis of SDRIFE that was treated with a prednisone taper...This case describes the second reported SDRIFE resulting from IVIG and is the first to describe successful avoidance of exanthem on subsequent exposures. With the change to Gamunex from Privigen formulation, the patient has tolerated the recommended treatment without further complications and remains infection free.
- |||||||||| Gamunex (intravenous normal human immunoglobulin 10%) / Bayer, Grifols, Kedrion
Trial completion date, Trial primary completion date: Intravenous Gammaglobulin for Sickle Cell Pain Crises (clinicaltrials.gov) - Oct 3, 2023
P1/2, N=300, Recruiting,
With the change to Gamunex from Privigen formulation, the patient has tolerated the recommended treatment without further complications and remains infection free. Trial completion date: Sep 2024 --> Dec 2025 | Trial primary completion date: Sep 2024 --> Dec 2025
- |||||||||| Gamunex (intravenous normal human immunoglobulin 10%) / Bayer, Grifols, Kedrion
Enrollment change, Trial completion date: Intravenous Gammaglobulin for Sickle Cell Pain Crises (clinicaltrials.gov) - Aug 1, 2023
P1/2, N=300, Recruiting,
Trial completion date: Sep 2024 --> Dec 2025 | Trial primary completion date: Sep 2024 --> Dec 2025 N=94 --> 300 | Trial completion date: Jul 2025 --> Sep 2024
- |||||||||| Gamunex (intravenous normal human immunoglobulin 10%) / Bayer, Grifols, Kedrion
Journal: Reply to: Intravenous immunoglobulin (Gamunex (Pubmed Central) - Apr 26, 2023
Long-term treatment of CIDP patients with IVIG 10% in real-world conditions maintained clinical stability on fatigue and depression over 96 No abstract available
- |||||||||| Gamunex (intravenous normal human immunoglobulin 10%) / Bayer, Grifols, Kedrion
Journal: Intravenous immunoglobulin (Gamunex (Pubmed Central) - Apr 17, 2023
No abstract available No abstract available
- |||||||||| Gamunex (intravenous normal human immunoglobulin 10%) / Bayer, Grifols, Kedrion
Trial completion date, Trial primary completion date: Intravenous Gammaglobulin for Sickle Cell Pain Crises (clinicaltrials.gov) - Jul 26, 2022
P1/2, N=94, Recruiting,
This analysis projects that Hizentra is likely associated with favorable economic benefit compared with IVIG in managing CIDP. Trial completion date: Jul 2024 --> Jul 2025 | Trial primary completion date: Sep 2023 --> Sep 2024
- |||||||||| Gamunex (intravenous normal human immunoglobulin 10%) / Bayer, Grifols, Kedrion
Trial completion date, Trial primary completion date: Intravenous Gammaglobulin for Sickle Cell Pain Crises (clinicaltrials.gov) - May 31, 2022
P1/2, N=94, Recruiting,
Trial completion date: Jul 2024 --> Jul 2025 | Trial primary completion date: Sep 2023 --> Sep 2024 Trial completion date: Jul 2023 --> Jul 2024 | Trial primary completion date: Sep 2022 --> Sep 2023
- |||||||||| Gamunex (intravenous normal human immunoglobulin 10%) / Bayer, Grifols, Kedrion, Zika virus immune globulin (ZIKV-IG) / Emergent Biosolutions
Journal: The Ability of Zika virus Intravenous Immunoglobulin to Protect From or Enhance Zika Virus Disease. (Pubmed Central) - Dec 22, 2021
Using this approach, we were able to define the unique in vivo dynamics of complex polyclonal antibodies, allowing for both enhancement and protection from flavivirus infection. Our results provide a novel understanding of how polyclonal antibodies interact with viruses with implications for the use of polyclonal antibody therapeutics and the development and evaluation of the next generation flavivirus vaccines.
- |||||||||| Octagam (intravenous normal human immunoglobulin) / Octapharma, Kiovig (human normal immunoglobulin 10%) / Takeda
In vitro comparison between different 10% intravenous immunoglobulin preparations () - Oct 7, 2021 - Abstract #DGHO2021DGHO_1143;
Although different IVIg preparations essentially consist of polyclonal IgG, the different purification processes lead to variations in other characteristics. The IqYmune manufacturing process developed with a QbD approach has generated a 10% IVIg having a higher level of quality and enhanced safety profile while maintaining a high level of efficacy.
- |||||||||| Gamunex (intravenous normal human immunoglobulin 10%) / Bayer, Grifols, Kedrion, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Now You See It, Now You Don’t: A Case of Transient Passage of Hepatitis B Core Antibody After Infusion of Intravenous Immunoglobulin (Shoreline Exhibit Hall) - Sep 8, 2021 - Abstract #ACG2021ACG_138;
Case Description/ A 76 year-old woman with stiff-person syndrome was treated with intravenous immunoglobulin therapy (Gamunex 60 grams every 6 weeks) from 2015 to 2019...She was started on entecavir...The pooling of plasma from 3,000-10,000 donors to create IVIG can lead to passive transfer of transient antibodies that wane with the 21-day half-life of IVIG. In the setting of increasing use of both IVIG and rituximab, this case serves to increase awareness of this phenomenon and to prevent confusion that can lead to unnecessary treatment of HBV, delays in starting rituximab, and needless anxiety for patients.
- |||||||||| Gamunex (intravenous normal human immunoglobulin 10%) / Bayer, Grifols, Kedrion
Enrollment change, Trial withdrawal: Intravenous Immunoglobulins in Complex-regional Pain Syndrome (clinicaltrials.gov) - Jul 15, 2021
P3, N=0, Withdrawn,
In the setting of increasing use of both IVIG and rituximab, this case serves to increase awareness of this phenomenon and to prevent confusion that can lead to unnecessary treatment of HBV, delays in starting rituximab, and needless anxiety for patients. N=36 --> 0 | Not yet recruiting --> Withdrawn
- |||||||||| Gamunex (intravenous normal human immunoglobulin 10%) / Bayer, Grifols, Kedrion
Clinical, Journal: IVMP+IVIG raises platelet counts faster than IVIG alone: results of a randomized, blinded trial in childhood ITP. (Pubmed Central) - May 15, 2021
P3
In such settings, the combination of IV methylprednisolone (IVMP) with IV immune globulin (IVIG) is used to rapidly increase platelet counts (PCs)...We conducted a randomized, double-blind, placebo-controlled study to evaluate the rapidity of the PC increment and associated adverse events (AEs) between 2 regimens: A (IV placebo) and B (IVMP 30 mg/kg), both given over 1 hour, followed in both cases by IVIG (Gamunex 10%) 1 g/kg over 2-3 hours in children 1-17 years old with primary ITP and PCs <20 × 109/L in whom physicians had decided to treat with IVIG...Our findings show a rapid response to IVIG with/without steroids and provide evidence to support the use of IVMP+IVIG in life-threatening situations. This trial was registered at www.clinicaltrials.gov as #NCT00376077.
- |||||||||| Gamunex (intravenous normal human immunoglobulin 10%) / Bayer, Grifols, Kedrion
Journal: Immune globulin subcutaneous, human 20% solution (Xembify®), a new high concentration immunoglobulin product for subcutaneous administration. (Pubmed Central) - Dec 17, 2020
The IGSC-C 20% formulation is based on knowledge acquired from the formulation of Immune Globulin Injection (Human),10% Caprylate/Chromatography Purified (IGIV-C 10%, Gamunex®-C)...These batches were characterized using a comprehensive panel of analytical testing. The new IGSC-C 20% product maintains the same composition, neutralizing activity, purity, and quality characteristics found in IGIV-C 10%.
- |||||||||| Gamunex (intravenous normal human immunoglobulin 10%) / Bayer, Grifols, Kedrion
Trial completion: Intravenous Immunoglobulin for PANDAS (clinicaltrials.gov) - Mar 17, 2020
P3, N=48, Completed,
The new IGSC-C 20% product maintains the same composition, neutralizing activity, purity, and quality characteristics found in IGIV-C 10%. Active, not recruiting --> Completed
- |||||||||| Privigen (human immune globulin intravenous 10%) / CSL Behring, Gamunex (intravenous normal human immunoglobulin 10%) / Bayer, Grifols, Kedrion, Octagam (intravenous normal human immunoglobulin) / Octapharma, Pfizer
Trial completion, Trial completion date: Ig PRx in AECOPD: Pilot Study (clinicaltrials.gov) - Nov 27, 2019
P2, N=48, Completed,
Active, not recruiting --> Completed Active, not recruiting --> Completed | Trial completion date: Jun 2020 --> Nov 2019
- |||||||||| Gamunex (intravenous normal human immunoglobulin 10%) / Bayer, Grifols, Kedrion
Clinical: Yes, stopping MMF, given as Gamunex via NJ in 3 patients with success in all 3. However, whether that was time, prior nitazox in 1 pt wo response, stopping MMF, all, or none is the ?. And now with IVIG shortage, whether you can get it? (Twitter) - Aug 13, 2019
- |||||||||| Gamunex (intravenous normal human immunoglobulin 10%) / Bayer, Grifols, Kedrion
Trial completion date, Trial primary completion date: Intravenous Gammaglobulin for Sickle Cell Pain Crises (clinicaltrials.gov) - Aug 5, 2019
P1/2, N=94, Recruiting,
Active, not recruiting --> Completed | Trial completion date: Jun 2020 --> Nov 2019 Trial completion date: Jul 2021 --> Jul 2023 | Trial primary completion date: Sep 2020 --> Sep 2022
- |||||||||| Gamunex (intravenous normal human immunoglobulin 10%) / Bayer, Grifols, Kedrion
Trial completion: IVIg-SFN: Intravenous Immunoglobulin Therapy for Small Fiber Neuropathy (clinicaltrials.gov) - Jul 5, 2019
P2, N=60, Completed,
Trial completion date: Jul 2021 --> Jul 2023 | Trial primary completion date: Sep 2020 --> Sep 2022 Active, not recruiting --> Completed
- |||||||||| Gamunex (intravenous normal human immunoglobulin 10%) / Bayer, Grifols, Kedrion
Trial completion: Intravenous Immunoglobulin (IVIG) in Lung Transplantation (clinicaltrials.gov) - Mar 5, 2019
P2, N=11, Completed,
The reason for low switching rates could not be assessed in this study; therefore, further studies are required to detect possible relevant differences in effectiveness and tolerability. Active, not recruiting --> Completed
- |||||||||| Privigen (human immune globulin intravenous 10%) / CSL Behring, Gamunex (intravenous normal human immunoglobulin 10%) / Bayer, Grifols, Kedrion, Octagam (intravenous normal human immunoglobulin) / Octapharma, Pfizer
Enrollment closed, Trial completion date: Ig PRx in AECOPD: Pilot Study (clinicaltrials.gov) - Nov 29, 2018
P2, N=48, Active, not recruiting,
Active, not recruiting --> Completed Recruiting --> Active, not recruiting | Trial completion date: Dec 2020 --> Jun 2020
- |||||||||| Gamunex (intravenous normal human immunoglobulin 10%) / Bayer, Grifols, Kedrion
Trial completion date, Trial primary completion date: IVIg-SFN: Intravenous Immunoglobulin Therapy for Small Fiber Neuropathy (clinicaltrials.gov) - Nov 23, 2018
P2, N=60, Active, not recruiting,
Recruiting --> Active, not recruiting | Trial completion date: Dec 2020 --> Jun 2020 Trial completion date: Sep 2018 --> Mar 2019 | Trial primary completion date: Sep 2018 --> Mar 2019
- |||||||||| Gamunex (intravenous normal human immunoglobulin 10%) / Bayer, Grifols, Kedrion
Trial completion date, Trial primary completion date: Intravenous Gammaglobulin for Sickle Cell Pain Crises (clinicaltrials.gov) - Aug 8, 2018
P1/2, N=94, Recruiting,
Trial completion date: Sep 2018 --> Mar 2019 | Trial primary completion date: Sep 2018 --> Mar 2019 Trial completion date: Jul 2020 --> Jul 2021 | Trial primary completion date: Sep 2019 --> Sep 2020
- |||||||||| Gamunex (intravenous normal human immunoglobulin 10%) / Bayer, Grifols, Kedrion
Enrollment closed: IVIg-SFN: Intravenous Immunoglobulin Therapy for Small Fiber Neuropathy (clinicaltrials.gov) - Aug 1, 2018
P2, N=60, Active, not recruiting,
Trial completion date: Jul 2020 --> Jul 2021 | Trial primary completion date: Sep 2019 --> Sep 2020 Recruiting --> Active, not recruiting
- |||||||||| Privigen (human immune globulin intravenous 10%) / CSL Behring, Gamunex (intravenous normal human immunoglobulin 10%) / Bayer, Grifols, Kedrion, Octagam (intravenous normal human immunoglobulin) / Octapharma, Pfizer
Enrollment open, Trial initiation date: Ig PRx in AECOPD: Pilot Study (clinicaltrials.gov) - Jan 24, 2017
P2, N=48, Recruiting,
Trial primary completion date: May 2017 --> Sep 2018 Not yet recruiting --> Recruiting | Initiation date: Mar 2016 --> Sep 2016
- |||||||||| Gamunex (intravenous normal human immunoglobulin 10%) / Bayer, Grifols, Kedrion
Trial primary completion date: IDIDM: IVIg for Demyelination in Diabetes Mellitus (clinicaltrials.gov) - Nov 14, 2016
P4, N=25, Recruiting,
Not yet recruiting --> Recruiting | Initiation date: Mar 2016 --> Sep 2016 Trial primary completion date: Feb 2017 --> Feb 2018
- |||||||||| Gamunex (intravenous normal human immunoglobulin 10%) / Bayer, Grifols, Kedrion
Enrollment open, Trial initiation date: IVIg-SFN: Intravenous Immunoglobulin Therapy for Small Fiber Neuropathy (clinicaltrials.gov) - Jul 13, 2016
P2, N=60, Recruiting,
Trial primary completion date: Feb 2017 --> Feb 2018 Not yet recruiting --> Recruiting | Initiation date: Feb 2016 --> Jul 2016
- |||||||||| Gamunex (intravenous normal human immunoglobulin 10%) / Bayer, Grifols, Kedrion, Gamunex-C (human immune globulin 10%- caprylate/ chromatography purified) / Kedrion, Grifols, Prolastin (alpha-1 antitrypsin inhibitor) / Grifols
Enrollment change: Use of Immune Globulin Intravenous (Human) To Treat Age-Related Macular Degeneration (clinicaltrials.gov) - Mar 21, 2016
P2, N=96, Completed,
Not yet recruiting --> Recruiting | Initiation date: Feb 2016 --> Jul 2016 N=57 --> 96
- |||||||||| Privigen (human immune globulin intravenous 10%) / CSL Behring, Gamunex (intravenous normal human immunoglobulin 10%) / Bayer, Grifols, Kedrion, Octagam (intravenous normal human immunoglobulin) / Octapharma, Pfizer
New P2 trial: Ig PRx in AECOPD: Pilot Study (clinicaltrials.gov) - Feb 24, 2016
P2, N=48, Not yet recruiting,
- |||||||||| Gamunex (intravenous normal human immunoglobulin 10%) / Bayer, Grifols, Kedrion
Enrollment change, Trial primary completion date: Intravenous Gammaglobulin for Sickle Cell Pain Crises (clinicaltrials.gov) - Jan 28, 2016
P1/2, N=94, Recruiting,
N=24 --> 9 N=60 --> 94 | Trial primary completion date: Jul 2014 --> Sep 2019
- |||||||||| Gamunex (intravenous normal human immunoglobulin 10%) / Bayer, Grifols, Kedrion
Trial completion, Trial primary completion date: Post-bypass Prophylactic IVIG in Infants and Neonates (clinicaltrials.gov) - Jul 16, 2015
P=N/A, N=50, Completed,
N=60 --> 94 | Trial primary completion date: Jul 2014 --> Sep 2019 Recruiting --> Completed | Trial primary completion date: Dec 2015 --> Jun 2015
- |||||||||| Gamunex (intravenous normal human immunoglobulin 10%) / Bayer, Grifols, Kedrion
Trial primary completion date: Post-bypass Prophylactic IVIG in Infants and Neonates (clinicaltrials.gov) - Jun 11, 2015
P=N/A, N=50, Recruiting,
Recruiting --> Completed | Trial primary completion date: Dec 2015 --> Jun 2015 Trial primary completion date: Mar 2015 --> Dec 2015
- |||||||||| Gamunex (intravenous normal human immunoglobulin 10%) / Bayer, Grifols, Kedrion
Trial initiation date: Post-bypass Prophylactic IVIG in Infants and Neonates (clinicaltrials.gov) - Jun 13, 2014
P=N/A, N=50, Recruiting,
Trial primary completion date: Mar 2015 --> Dec 2015 Initiation date: Jan 2014 --> May 2014
- |||||||||| Gamunex (intravenous normal human immunoglobulin 10%) / Bayer, Grifols, Kedrion
Enrollment open: Post-bypass Prophylactic IVIG in Infants and Neonates (clinicaltrials.gov) - Jun 13, 2014
P=N/A, N=50, Recruiting,
Initiation date: Jan 2014 --> May 2014 Not yet recruiting --> Recruiting
- |||||||||| Gamunex (intravenous normal human immunoglobulin 10%) / Bayer, Grifols, Kedrion
Enrollment change: Intravenous Immunoglobulin for PANDAS (clinicaltrials.gov) - Aug 2, 2013
P3, N=45, Active, not recruiting,
Recruiting --> Terminated; Study was terminated due to the death of the PI. N=32 --> 45
- |||||||||| Gamunex (intravenous normal human immunoglobulin 10%) / Bayer, Grifols, Kedrion
Enrollment closed: Intravenous Immunoglobulin for PANDAS (clinicaltrials.gov) - Jul 23, 2013
P3, N=45, Active, not recruiting,
N=32 --> 45 Recruiting --> Active, not recruiting
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