A clinical trial to evaluate the efficacy and safety of sofosbuvir/velpatasvir and ribavirin for 12 weeks in people with hepatitis C infection and liver scarring.
- Conditions
- Chronic hepatitis C virus infectionMedDRA version: 20.0 Level: PT Classification code 10019744 Term: Hepatitis C System Organ Class: 10021881 - Infections and infestationsMedDRA version: 20.1 Level: PT Classification code 10008912 Term: Chronic hepatitis C System Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2016-003066-10-FR
- Lead Sponsor
- Gilead Sciences International Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 32
1) Willing and able to provide written informed consent
2) Males and females, age = 18 years old
3) A body mass index (BMI) of = 18 kg/m2
4) Chronic HCV infection (= 6 months) as documented by either prior medical history or liver biopsy
5) Quantifiable HCV RNA at Screening
6) Subjects may be non-transplanted or with recurrent HCV post-liver transplant. a. If listed for liver transplant, then the projected date of transplant must be =12 weeks after Day1 of treatment b. If post-liver transplant, then Day1 must be = 6 months from date of transplant
7) CPT score of 10 to 12, inclusive, as determined at Screening
8) Liver imaging within 6 months of Day 1 to exclude hepatocellular carcinoma (HCC)
9) If treatment-experienced, the most recent HCV treatment must have been completed at least 8 weeks prior to Screening
10) Females of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day 1 prior to randomization
11) Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
12) Female subjects must agree to refrain from egg donation and in vitro fertilization during treatment until at least 30 days after the last dose of SOF/VEL or 6 months after the last dose of RBV, whichever occurs last
13) Lactating females must agree to discontinue nursing before the study drugs are administered
14) Male subjects must agree to refrain from sperm donation from the date of screening until at least 7 months after the last dose of RBV or 30 days after the last dose of SOF/VEL, whichever occurs last
15) Subject must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
1) Current or prior history of any of the following: a) Clinically significant medical or psychiatric illness or subjects is currently under evaluation for a potentially clinically significant illness (other than HCV or comorbidities associated with advanced liver disease except as noted below) or any other medical or psychiatric disorder that may interfere with subject treatment, assessment or compliance with the protocol b) Gastrointestinal disorder or post-operative condition that could interfere with the absorption of the study drug c) Difficulty with blood collection and/or poor venous access for the purposes of phlebotomy d) Significant pulmonary disease, significant cardiac disease or porphyria e) Malignancy within the 5 years prior to screening, with the exception of specific cancers that have been cured by surgical resection (basal cell skin cancer, etc.). Subjects under evaluation for possible malignancy are not eligible f) Significant drug allergy (such as anaphylaxis or hepatotoxicity)
2) Any history of organ transplant other than liver or kidney
3) Chronic liver disease of a non-HCV etiology (eg, hemochromatosis, Wilson’s disease, alfa-1 antitrypsin deficiency, cholangitis)
4) Inability to exclude HCC by imaging within 6 months of Day 1 (including indeterminate hepatic nodule meeting OPTN Class 5 criteria, defined by arterial enhancement with washout on portal venous/delayed phase OR rate of growth maximum diameter increase in the absence of ablative therapy by 50% or more documented on serial MRI or CT obtained <6 month apart)
5) Alpha-fetoprotein (AFP) > 50 unless negative imaging for hepatic masses within the last 6 months or during screening
6) Active spontaneous bacterial peritonitis at Screening
7) Infection requiring systemic antibiotics at the time of Screening
8) Evidence of fibrosing cholestatic hepatitis at Screening
9) Life threatening SAE during Screening
10) Active variceal bleeding within 6 months of Screening
11) Prior placement of a portosystemic shunt (such as TIPS)
12) ECG with clinically significant abnormalities
13) Laboratory parameters at screening
14) Hepatitis B surface antigen positive at Screening
15) Infection with human immunodeficiency virus (HIV)
16) Clinically-relevant alcohol or drug abuse within 12 months of screening. A positive drug screen will exclude subjects unless it can be explained by a prescribed medication; the diagnosis and prescription must be approved by the Investigator.
17) Prior exposure to any HCV NS5A inhibitor
18) Current use of corticosteroids at any dose >10 mg of prednisone/day (or equivalent dose of corticosteroid)
19) Use of any prohibited concomitant medications as described in Section 5.5
20) Use of GM-CSF, epoetin alfa or other hematopoietic stimulating agents within 2 weeks of Screening.
21) Male with pregnant female partner.
22) History of clinically significant hemoglobinopathy (eg, sickle cell disease, thalassemia)
23) Contraindications to RBV therapy
24) Known hypersensitivity to VEL, RBV, SOF, the metabolites, or formulation excipients
25) Participation in a clinic
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method