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NCT03619837: PRO-ACT:

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

Completed Phase 4 Results posted Last updated 3 March 2021
What this trial tests

Phase 4 trial testing Sofosbuvir/Velpatasvir in Hepatitis C in 122 participants. Completed in 13 August 2020.

Timeline
15 July 2018
Primary endpoint
21 December 2019
13 August 2020

Quick facts

Lead sponsorUniversity of California, San Francisco
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposeother
Enrollment122
Start date15 July 2018
Primary completion21 December 2019
Estimated completion13 August 2020
Sites6 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of California, San Francisco

Who can join

Eligibility, any sex, with Hepatitis C or Transplantation Disease Transmission. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Proportion of Participants With HCV RNA Level Below Limits of Quantification (LOQ) Primary · 12 weeks after end of treatment

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 RNA after treatment week 1. Safety was measured as the adverse events and serious adverse events att

GroupValue95% CI
Treatment Arm23
Safety as Measured by the Proportion of Participants Who Prematurely Discontinue Antiviral Therapy Before the Planned End of Treatment Secondary · 12 weeks after start of treatment

1 of 23 patients prematurely discontinued antiviral therapy due to intercurrent graft-versus-host disease that progressed to multiorgan failure.

GroupValue95% CI
Treatment Arm1
Survival Rate of Patients and Their Allografts 6 Months Post Transplant Secondary · 6 months from time of liver transplant

Graft and patient survival at 24 weeks after transplant

GroupValue95% CI
Treatment Arm23

Adverse events — posted to ClinicalTrials.gov

Time frame: 6 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Transplant Recipients
Serious: 13/24 (54%)
Deaths: 1/24

Serious adverse events (15 terms)

ReactionSystemTransplant Recipients
FeverInfections and infestations
CholangitisHepatobiliary disorders
FractureMusculoskeletal and connective tissue disorders
BleedingSurgical and medical procedures
GVHDImmune system disorders
RejectionImmune system disorders
Biliary sclerosisHepatobiliary disorders
cardiomyopathyCardiac disorders
Delayed graft functionRenal and urinary disorders
Ureteral strictureRenal and urinary disorders
Supraventricular tachycardiaCardiac disorders
ColitisGastrointestinal disorders
PancreatitisSurgical and medical procedures
Gastrointestinal bleedingGastrointestinal disorders
hyperkalemiaRenal and urinary disorders
Other adverse events (6 terms — click to expand)

ReactionSystemTransplant Recipients
abnormal liver testsHepatobiliary disorders
anemiaBlood and lymphatic system disorders
nauseaGastrointestinal disorders
hematuriaRenal and urinary disorders
Elevated creatinineRenal and urinary disorders
leukopeniaBlood and lymphatic system disorders

Most-reported serious reactions: Fever, Cholangitis, Fracture, Bleeding, GVHD, Rejection, Biliary sclerosis, cardiomyopathy.

Data from ClinicalTrials.gov NCT03619837 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Preemptive Treatment With Elbasvir and Grazoprevir for Hepatitis C-Viremic Donor to Uninfected Recipient Kidney Transplantation.
    Sise ME, Strohbehn IA, Chute DF, Gustafson J, et al · · 2020 · cited 15× · PMID 32280841 · DOI 10.1016/j.ekir.2020.01.001

Verify or expand the search:

Other trials of Sofosbuvir/Velpatasvir

Trials testing the same drug.

Other recruiting trials for Hepatitis C

Currently open trials in the same condition.

Other University of California, San Francisco trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03619837.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing