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NCT03619837 · ClinicalTrials.gov registry record · Phase 4

Prevention of De Novo HCV With Antiviral HCV Therapy Post-Liver and Post-Kidney Transplant

A Phase 4 study of Hepatitis C and Transplantation Disease Transmission, sponsored by University of California, San Francisco.

Completed
Registry status
Phase 4
Development phase
122
Enrollment target
6
Study locations

NCT03619837: Completed Phase 4 study of Hepatitis C and Transplantation Disease Transmission, sponsored by University of California, San Francisco.

NCT03619837 is a Phase 4 study of Hepatitis C and Transplantation Disease Transmission that has completed, run by University of California, San Francisco. The registered enrollment target is 122 participants, below the 1,889-participant average among 106 other Hepatitis C trials with a reported enrollment target (94% lower). The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03619837, a Phase 4 study of Hepatitis C and Transplantation Disease Transmission, has completed, sponsored by University of California, San Francisco.

COMPLETED
Registry status
Phase 4
Development phase
122 participants
Enrollment target
6
Study locations

Study Summary

In this study, subjects that do not have Hepatitis C virus (HCV) will be transplanted with livers or kidneys from donors who do have HCV. Medications that are used to treat HCV will be given to the study subjects shortly after transplant to protect them from developing the problems HCV can cause to the liver.

Primary Outcome

The primary outcome was sustained virologic response, defined as HCV RNA below the lower limit of quantification 12 weeks after treatment completion (SVR12). Secondary outcomes included the proportion of patients with SVR24 defined as HCV RNA \< lower limit of quantification 24 weeks after the end of treatment; with viral relapse defined as HCV RNA \<LLOQ at end of treatment with subsequent quantifiable HCV RNA; and with on-treatment virologic breakthrough defined as \> 1 log increase in viral R

Interventions

  • DRUG Sofosbuvir/Velpatasvir
  • DRUG Sofosbuvir/Velpatasvir/Voxilaprevir

Study Locations (6)

Texas

  • Baylor University Medical Center - Dallas - Dallas
  • Houston Methodist Hospital - Houston

California

  • University of California, San Francisco - San Francisco

Colorado

  • University of Colorado Denver - Aurora

Georgia

  • Piedmont Research Institute - Atlanta

New York

  • Columbia University - New York

Trial Details

FieldValue
Enrollment Target 122 participants
Start Date 2018-07-15
Est. Completion 2020-08-13
Phase Phase 4

What the finished NCT03619837 record still lists

NCT03619837 is an interventional study that assigns participants to a tested intervention. The registered 122 participants enrollment target is mid-sized for trials with a published cap, below the 1,889-participant average among 106 other Hepatitis C trials with a reported enrollment target (94% lower).

The record links to 2 conditions, with Hepatitis C appearing as the primary indexed condition, and to 2 interventions - of which Sofosbuvir/Velpatasvir is the first listed.

NCT03619837 lists 6 locations in 5 states (Texas, California, Colorado).

Frequently Asked Questions

What is clinical trial NCT03619837 about?

NCT03619837 is a clinical study titled "Prevention of De Novo HCV With Antiviral HCV Therapy Post-Liver and Post-Kidney Transplant". In this study, subjects that do not have Hepatitis C virus (HCV) will be transplanted with livers or kidneys from donors who do have HCV. Medications that are used to treat HCV will be given to the study subjects shortly after transplant to protect them from developing the problems HCV can cause to ...

What is the current status of trial NCT03619837?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 122 participants. The study started on 2018-07-15. Estimated completion is 2020-08-13.

What conditions does trial NCT03619837 study?

This clinical trial studies the following conditions: Hepatitis C, Transplantation Disease Transmission.

What interventions are being tested in trial NCT03619837?

The interventions under investigation include: Sofosbuvir/Velpatasvir (DRUG), Sofosbuvir/Velpatasvir/Voxilaprevir (DRUG).

Who is sponsoring clinical trial NCT03619837?

This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03619837 being conducted?

This trial has 6 study locations across California, Colorado, Georgia, New York, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Hepatitis C

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03619837's enrollment target sits among peer trials

122 49th of 106 higher than 58 of 106 other Hepatitis C trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Hepatitis C 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 NCT03619837, the US trial registry maintained by the National Library of Medicine. NCT03619837 (mid enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.