A trial investigating the safety and efficacy of the drug combination Sofosbuvir/Velpatasvir/GS-9857 for 8 weeks against Sofosbuvir/Velpatasvir for 12 weeks for subjects with hepatitis C

• Register: EUCTR
• Last refreshed on: 3 July 2017
• Main ID: EUCTR2015-002996-12-DE
• Date of registration: 03/11/2015
• Prospective Registration: Yes
• Primary sponsor: Gilead Sciences, Inc.
• Public title: A trial investigating the safety and efficacy of the drug combination Sofosbuvir/Velpatasvir/GS-9857 for 8 weeks against Sofosbuvir/Velpatasvir for 12 weeks for subjects with hepatitis C
• Scientific title: A Phase 3, Global, Multicenter, Randomized, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination for 8 Weeks and Sofosbuvir/Velpatasvir for 12 Weeks in Subjects with Chronic Genotype 3 HCV Infection and Cirrhosis
• Date of first enrolment: 16/02/2016
• Target sample size: 200
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-002996-12
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Australia, Canada, France, Germany, New Zealand, United Kingdom, United States

Contacts

• Name: Clinical Trials Mailbox
• Affiliation: Gilead Sciences International Ltd.

• Name: Clinical Trials Mailbox
• Affiliation: Gilead Sciences International Ltd.

Key inclusion & exclusion criteria

Inclusion criteria:
1) Willing and able to provide written informed consent
2) Male or female, age =18 years
3) Body mass index (BMI) = 18 kg/m2
4) HCV RNA = 104 IU/mL at Screening
5) HCV genotype 3 at Screening, as determined by the central laboratory
6) Chronic HCV infection (= 6 months) documented by prior medical history or liver biopsy.
7) HCV treatment status of one of the following:
a) Treatment-naïve with no prior exposure to any IFN, RBV, or approved or experimental HCV-specific DAA
b) Treatment experienced with an IFN-based regimen and no prior exposure to an approved or experimental HCV-specific DAA
8) Presence of cirrhosis is defined as in the protocol
9) Liver imaging within 6 months prior to Day 1 is required to exclude hepatocellular carcinoma (HCC)
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 enrollment
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) Lactating females must agree to discontinue nursing before starting study drug.
13) Subject must be of generally good health, with the exception of chronic HCV infection, as determined by the investigator
14) 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 180
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion criteria:
1) Current or prior history of any of the following:
a. Clinically significant illness (other than HCV) or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol; subjects currently under evaluation for a potentially clinically significant illness (other than HCV) are also excluded
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. Hepatic decompensation (e.g., clinical ascites, encephalopathy, and/or variceal hemorrhage)
e. Solid organ transplantation
f. Significant cardiac disease
g. Unstable psychiatric condition including hospitalization, suicide attempt, and/or a period of disability as a result of their psychiatric illness within 2 years prior to Screening
h. Malignancy within the 5 years prior to Screening, with the exception of specific cancers that have been cured by surgical resection.
i. Significant drug allergy (e.g., hepatotoxicity)
2) Screening ECG with clinically significant abnormalities
3) Subjects with laboratory parameters at screening as defined in the protocol
4) Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, Wilson’s disease, alfa-1 antitrypsin deficiency, cholangitis)
5) Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
6) 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
7) Use of any prohibited concomitant medications
8) Known hypersensitivity to the study drug, the metabolites, or formulation excipient.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Virus Diseases [C02]

Chronic Hepatitis C virus infection
MedDRA version: 18.1 Level: PT Classification code 10019744 Term: Hepatitis C System Organ Class: 10021881 - Infections and infestations
MedDRA version: 18.1 Level: PT Classification code 10008912 Term: Chronic hepatitis C System Organ Class: 10021881 - Infections and infestations

Intervention(s)

Product Code: SOF/GS-5816/GS-9857
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: sofosbuvir
CAS Number: 1190307-88-0
Other descriptive name: SOFOSBUVIR
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 400-
INN or Proposed INN: velpatasvir
Other descriptive name: GS-5816
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
INN or Proposed INN: GS-9857
Other descriptive name: GS-9857
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-

Product Code: SOF/GS-5816
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: sofosbuvir
CAS Number: 1190307-88-0
Other descriptive name: SOFOSBUVIR
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 400-
INN or Proposed INN: velpatasvir
Current Sponsor code: GS-5816
Other descriptive name: GS-5816
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)

Main Objective: To determine the efficacy of treatment with sofosbuvir (SOF)/velpatasvir (VEL)/GS-9857 fixed dose combination (FDC) for 8 weeks and of treatment with SOF/VEL FDC for 12 weeks as measured by the proportion of subjects with sustained viral response 12 weeks after cessation of treatment (SVR12)

To evaluate the safety and tolerability of each treatment regimen

Secondary Objective: To determine the proportion of subjects who attain SVR at 4 and 24 weeks after cessation of treatment (SVR4 and SVR24)
To evaluate the proportion of subjects with virologic failure
To evaluate the kinetics of circulating HCV RNA during treatment and after cessation of treatment
To evaluate the emergence of viral resistance to SOF, VEL and GS-9857 during treatment and after cessation of treatment

Primary end point(s): The primary efficacy endpoint is the proportion of subjects with SVR12 (HCV RNA < LLOQ 12 weeks after cessation of treatment) in the Full Analysis Set (FAS).

The primary safety endpoint is any AE that led to permanent discontinuation of study drug.

Timepoint(s) of evaluation of this end point: 12 weeks post last treatment dose

Secondary Outcome(s)

Secondary end point(s): Secondary endpoints include the following:
- The proportion of subjects with HCV RNA < LLOQ at 4 and 24 weeks after cessation of treatment (SVR4 and SVR24)
- The proportion of subjects with HCV RNA < LLOQ on treatment
- HCV RNA change from Baseline/Day 1
- The proportion of subjects with virologic failure

Timepoint(s) of evaluation of this end point: Secondary efficacy endpoints will be assessed on treatment or 4 and 24 weeks following discontinuation of treatment

Secondary ID(s)

GS-US-367-1173

Source(s) of Monetary Support

Gilead Sciences, Inc.