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NCT01804829 · ClinicalTrials.gov registry record · Phase 3

Civacir® Polyclonal Immune Globulin (IgG) to Prevent Hepatitis C Virus (HCV) Recurrence in Liver Transplant Patients.

A Phase 3 study, sponsored by Biotest Pharmaceuticals Corporation.

Completed
Registry status
Phase 3
Development phase
80
Enrollment target

NCT01804829: Completed Phase 3 study, sponsored by Biotest Pharmaceuticals Corporation.

NCT01804829 is a Phase 3 study that has completed, run by Biotest Pharmaceuticals Corporation. The registered enrollment target is 80 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01804829, a Phase 3 study, has completed, sponsored by Biotest Pharmaceuticals Corporation.

COMPLETED
Registry status
Phase 3
Development phase
80 participants
Enrollment target

Study Summary

The purpose of this study is to test the safety and efficacy of Civacir® to prevent the recurrence of Hepatitis C Virus (HCV) after liver transplant.

Primary Outcome

The primary objective is to assess the effect of administering Civacir® anti-HCV immunoglobulin therapy on prevention of orthotopic liver transplant (OLT) HCV recurrence, as measured by the proportion of subjects with unquantifiable HCV RNA levels at 22 weeks post-OLT, compared to the control group (not treated with Civacir® and considered standard of care).

Interventions

  • BIOLOGICAL Civacir® 10%

Trial Details

FieldValue
Enrollment Target 80 participants
Start Date 2013-06
Est. Completion 2016-06
Phase Phase 3

What the finished NCT01804829 record still lists

NCT01804829 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower).

The record links to 0 conditions, and to 1 intervention - of which Civacir® 10% is the first listed.

NCT01804829 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01804829 about?

NCT01804829 is a clinical study titled "Civacir® Polyclonal Immune Globulin (IgG) to Prevent Hepatitis C Virus (HCV) Recurrence in Liver Transplant Patients.". The purpose of this study is to test the safety and efficacy of Civacir® to prevent the recurrence of Hepatitis C Virus (HCV) after liver transplant.

What is the current status of trial NCT01804829?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 80 participants. The study started on 2013-06. Estimated completion is 2016-06.

What interventions are being tested in trial NCT01804829?

The interventions under investigation include: Civacir® 10% (BIOLOGICAL).

Who is sponsoring clinical trial NCT01804829?

This trial is sponsored by Biotest Pharmaceuticals Corporation, which has 5 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01804829's enrollment target sits among peer trials

80 1755th of 2000 higher than 233 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01804829, the US trial registry maintained by the National Library of Medicine. NCT01804829 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.