Bioequivalence Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Gammaplex® 10 and Gammaplex® 5% in Primary Immunodeficiency Diseases (GMX07)
A Phase III, Multicenter, Open-label, Randomized, Two-Period, Crossover Bioequivalence Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Gammaplex® 10 and Gammaplex® 5% in Primary Immunodeficiency Diseases
Sponsor: Bio Products Laboratory
This PHASE3 trial investigates Common Variable Immunodeficiency and Hyper-IgM Syndrome and is currently completed. Bio Products Laboratory leads this study, which shows 10 recorded versions since 2014 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.
Status Flow
Change History
10 versions recorded-
Sep 2025 — Present [monthly]
Completed PHASE3
-
Sep 2024 — Sep 2025 [monthly]
Completed PHASE3
-
Jul 2024 — Sep 2024 [monthly]
Completed PHASE3
-
Jan 2023 — Jul 2024 [monthly]
Completed PHASE3
-
Dec 2022 — Jan 2023 [monthly]
Completed PHASE3
▶ Show 5 earlier versions
-
Jan 2021 — Dec 2022 [monthly]
Completed PHASE3
-
Jun 2018 — Jan 2021 [monthly]
Completed PHASE3
-
May 2017 — Jun 2018 [monthly]
Completed PHASE3
-
Feb 2017 — May 2017 [monthly]
Completed PHASE3
-
Jan 2017 — Feb 2017 [monthly]
Completed PHASE3
First recorded
Feb 2014
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Bio Products Laboratory
For direct contact, visit the study record on ClinicalTrials.gov .