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

NCT03619837 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 18-24323
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Hepatitis C; Transplantation Disease Transmission

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants With HCV RNA Level Below Limits of Quantification (LOQ)

  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 attributed by the investigator to HCV infection or antiviral therapy; the proportion of recipients who prematurely discontinued antiviral therapy before the planned end of treatment; and patient and graft survival at 6 months post-transplant.

  12 weeks after end of treatment

Secondary Outcomes (1)

• Safety as Measured by the Proportion of Participants Who Prematurely Discontinue Antiviral Therapy Before the Planned End of Treatment

  12 weeks after start of treatment

Other Outcomes (1)

• Survival Rate of Patients and Their Allografts 6 Months Post Transplant

  6 months from time of liver transplant

Study Arms (1)

Treatment Arm

EXPERIMENTAL

Single Arm: Sofosbuvir/Velpatasvir Dosage: 400mg/100mg. Once daily for 12 weeks.

Drug: Sofosbuvir/Velpatasvir; Drug: Sofosbuvir/Velpatasvir/Voxilaprevir

Interventions

Sofosbuvir/Velpatasvir DRUG

Sofosbuvir/Velpatasvir starting early post-transplant for total of 12 weeks.

Treatment Arm

Sofosbuvir/Velpatasvir/Voxilaprevir DRUG

Only for patients who fail initial treatment with Sofosbuvir/Velpatasvir. Dosage: 400mg/100mg/100mg daily for 12 weeks.

Treatment Arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (≥ 18 year-old), wait-listed for primary kidney or liver transplant without a potential suitable living donor or for simultaneous liver kidney transplant;
• HCV non-infected at the time of transplant. Subjects who were previously HCV infected but who have had documented SVR12 are eligible to participate;
• Agree to use two methods of birth control during the study;
• Donor characteristics: serum HCV NAT-positive and negative for hepatitis B surface antigen. For liver transplant: pre-donation liver biopsy with no fibrosis (F0) or minimal fibrosis (F1). For kidney transplant: kidney donor profile index \< 85%.

You may not qualify if:

• Donor and/or recipient HIV infection
• Subject pregnant or nursing
• Donor and/or recipient Hepatitis B surface antigen positive
• Kidney-pancreas transplant
• Single organ liver recipients who received hemodialysis for more than 7 days prior to liver transplantation
• Kidney recipients: on dialysis for \> 5 years at time of Screening; subjects sensitized with panel reactive antibody \> 80%; for single organ kidney transplant, subjects with advanced liver fibrosis (Knodell stage 3) or cirrhosis
• Individuals being treated with and needing to continue rifabutin, rifampin, carbamazepine, phenytoin, phenobarbital, oxcarbazepine, St. John's wort (Hypericum perforatum), medium- or high-dose rosuvastatin or atorvastatin, or high-dose proton pump inhibitors (See Concomitant Medications).
• Individuals treated with amiodarone within 42 days of organ transplant.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (6)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

Piedmont Research Institute

Atlanta, Georgia, 30309, United States

Location

Columbia University

New York, New York, 10032, United States

Location

Baylor University Medical Center - Dallas

Dallas, Texas, 75246, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

sofosbuvir-velpatasvir drug combination; sofosbuvir velpatasvir voxilaprevir drug combination

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Results Point of Contact

• Title: Norah Terrault
• Organization: University of Southern California

terrault@usc.edu

323-442-5100

Study Officials

• Claus Niemann, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2018
• First Posted: August 8, 2018
• Study Start: July 15, 2018
• Primary Completion: December 21, 2019
• Study Completion: August 13, 2020
• Last Updated: March 3, 2021
• Results First Posted: March 3, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)