CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 38 enrolled
Drug / intervention
Subgambiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01884311
NCT01884311Phase 3Completed
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A Phase III, Multicenter, Open-Label Study to Evaluate the Pharmacokinetics and Safety of Subgam-VF in Primary Immunodeficiency Diseases

Bio Products Laboratory·interventional·Posted Jun 24, 2013·Updated Sep 12, 2018

In Brief

A Phase 3 clinical trial evaluating Subgam for Primary Immune Deficiency Disorders and 3 related conditions. Completed, enrolled 38 participants across 16 sites.

Detailed Summary

The main objective of the study is to determine the pharmacokinetics profile of Subgam-VF. The secondary objectives are to assess the safety of Subgam-VF and refine the dose adjustment coefficient for Subgam-VF needed for subjects switching from prior intravenous immunoglobulin (IGIV) therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Immune Deficiency Disorders, Common Variable Immunodeficiency, X-linked Agammaglobulinaemia, Hyperimmunoglobulin M Syndrome
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJun 24, 2013
Enrollment StartAug 20, 2015
Primary CompletionMay 25, 2017
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 13.0 years ago

Interventions

Subgambiological

Subgam-VF dose will be given as 1.37 of the established IGIV dose (expressed in mg/kg/week) for 26 weeks (26 infusions) beginning one week after the last IGIV infusion. Dose of Subgam-VF will then be adjusted based on the ratio of the Immunoglobulin G (IgG) average concentration achieved with Subgam-VF compared to IGIV.