Lung Transplantation in Chronic HCV Infection With Post Transplant EPCLUSA Treatment

NCT03207399 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: Pro00074361
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate whether treatment with Epclusa (sofosbuvir/velpatasvir) after lung transplantation in individuals with chronic hepatitis C infection is feasible, safe and effective at curing HCV.

Conditions

Hepatitis C, Chronic; Lung Transplant

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Sustained Virologic Response 12 Weeks (SVR 12) in Those Treated With EPCLUSA.

  Sustained Virologic Response 12 weeks (SVR 12) in those treated with EPCLUSA.

  12 weeks

• Number of Patients That Reported an Adverse Event Resulting in Discontinuation of EPCLUSA

  Adverse events resulting in discontinuation of EPCLUSA

  1 year

• Number of Patients Eligible for EPCLUSA Treatment

  Eligibility for EPCLUSA treatment within 12 months of lung transplant

  within 12 months of lung transplant

Secondary Outcomes (6)

• Change in Serum HCV RNA Levels

  12, 24, and 48 weeks after initiation of EPCLUSA

• Number of Participants With Adverse Events Requiring Temporary Interruption of EPCLUSA Therapy

  1 year

• Patient Survival

  90 days post-transplant

• Patient Survival

  1 year post-tranplant

• Patient Survival

  90 days post-transplant

Study Arms (1)

Epclusa

OTHER

Epclusa (sofosbuvir 400mg/velpatasvir 100mg) 1 tablet oral or via tube daily for 12 weeks, taken with or without food.

Drug: Epclusa

Interventions

Epclusa DRUG

Patients will be treated with this drug for 12 weeks post lung transplant.

Epclusa

Eligibility Criteria

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

You may qualify if:

• HCV RNA \>= 10\^3 IU/ml at screening
• Chronic HCV infection, defined as positive HCV antibody and/or HCV RNA more than 6 months prior to screening
• HCV Genotype 1, 2, 3, 4, 5 or 6
• Otherwise eligible for lung transplant at study site

You may not qualify if:

• Age \<18
• Treatment with any of the following agents:
• Amiodarone. Subjects previously treated with amiodarone must have stopped the amiodarone at least 60 days prior to day 1 SOF/VEL
• Carbamazepine, phenytoin, phenobarbital, oxcarbazepine
• Rifabutin, rifampin or rifapentine
• HIV regimens containing tenofovir or tipranavir/ritonavir
• St John's wort
• PPIs, including: Omeprazole, pantoprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole
• Modafinil
• Have any serious or active medical or psychiatric illness which, in the opinion of the investigator, would interfere with subject treatment, assessment or compliance
• Hepatitis B surface antigen positive
• History of hepatic encephalopathy or variceal hemorrhage
• Abnormal hematological and biochemical parameters, including:
• Hemoglobin \<8g/dL
• Platelets \<= 50,000/mm\^3

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

sofosbuvir-velpatasvir drug combination

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Enrollment in the clinical trial did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results.

Results Point of Contact

• Title: Dr. Omar Mohamedaly
• Organization: Duke University Medical Center

omar.mohamedaly@duke.edu

919-684-4589

Study Officials

• Omar Mohamedaly, MD

  Duke Heath

  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: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2017
• First Posted: July 2, 2017
• Study Start: September 15, 2017
• Primary Completion: March 25, 2019
• Study Completion: March 25, 2019
• Last Updated: September 11, 2019
• Results First Posted: September 11, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)