An international study to assess the safety and efficacy of a combination of new investigational drugs in patients with chronic hepatitis C virus infection who have previously failed treatment.
- Conditions
- Chronic Genotype 1 Hepatitis C Virus InfectionMedDRA version: 18.0Level: LLTClassification code 10019751Term: Hepatitis C virusSystem Organ Class: 100000004848Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2013-002296-17-FR
- Lead Sponsor
- Gilead Sciences, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 155
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. Both HCV Genotype 1 and HCV RNA >/= 104 IU/mL at Screening
5. Prior virologic failure after treatment with a PEG-IFN, RBV, and a protease inhibitor following documented prior virology failure after treatment with a PEG-IFN+RBV regimen. The subject’s medical records must include sufficient detail of prior virologic failure to allow for categorization of prior response during both prior treatment periods (Reference Section 6.4.2), as either:
i. Non-Responder: Subject did not achieve undetectable HCV RNA levels while on treatment, or
ii. Breakthrough: Subject achieved undetectable HCV RNA levels during treatment but subsequently had detectable HCV RNA while continuing treatment
iii. Relapse: Subject achieved undetectable HCV RNA levels during treatment maintained undetectable HCV RNA for the duration of treatment or achieved undetectable HCV RNA within 4 weeks of the
end of treatment but did not achieve a SVR
iv. Stopped due to AE
6. Evidence of cirrhosis defined as any of the following:
-Any biopsy showing cirrhosis
-Transient elastography (where approved) showing cirrhosis results >12.5 kPa
-A FibroTest® score of >0.75 AND an AST:platelet ratio index (APRI) of >2 performed during screening
7. Liver imaging within 3 months of Day 1 excluding HCC
8. Screening ECG without clinically significant abnormalities
9. Subjects must have the following laboratory parameters at screening:
a. ALT b. AST c. Direct bilirubin d. Platelets >/= 50,000
e. HbA1c f. Creatinine clearance (CLcr) >/= 50 mL /min, as calculated by the Cockcroft-Gault equation
g. Hemoglobin >/= 11 g/dL
h. Albumin >/= 3g/dL
i. INR = 1.5 x ULN unless subject has known hemophilia or is stable on an anticoagulant regimen affecting INR.
10. Subject has not been treated with any investigational drug or device within 30 days of the Screening visit.
11. A negative serum pregnancy test is required for female subjects (unless surgically sterile or greater than two years post-menopausal; see Appendix 4 for definitions).
12. Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception as described in Appendix 4.
13. 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 90 days after their last dose of study drug if not taking RBV.
14. Subject must be of generally good health, with the exception of chronic HCV infection, as determined by the Investigator.
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 130
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
1. Current or prior history of any of the following:
a. Clinically-significant illness (other than HCV) or any other major medical disorder that, in the opinion of the investigator, 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 (for example, gastric bypass or severe ulcerative colitis).
c. Difficulty with blood collection and/or poor venous access for the purposes of phlebotomy.
d. Clinical hepatic decompensation (ie, clinical ascites, encephalopathy or variceal hemorrhage).
e. Solid organ transplantation.
f. Significant pulmonary disease or significant cardiac.
g. Psychiatric hospitalization, suicide attempt, and/or a period of disability as a result of their psychiatric illness within the last 2 years. Subjects with psychiatric illness that is well-controlled on a stable treatment regimen for at least 12 months prior to randomization or has not required medication in the last 12 months may be included.
h. Malignancy within 5 years prior to screening, with the exception of specific cancers that are entirely cured by surgical resection (basal cell skin cancer, etc). Subjects under evaluation for possible malignancy are not eligible.
i. Significant drug allergy (such as anaphylaxis or hepatotoxicity).
2. Prior exposure to approved or experimental HCV-specific DAA(s), other than a NS3/4A protease inhibitor.
3. Pregnant or nursing female, or male with pregnant female partner.
4. Chronic liver disease of a non-HCV etiology (eg, hemochromatosis, Wilson’s disease, alfa-1 antitrypsin deficiency, cholangitis).
5. Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV).
6. Clinically-relevant drug or alcohol 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. Contraindications to RBV therapy, including significant history of clinically significant hemoglobinopathy (eg, sickle cell disease, thalassemia).
8. Use of any prohibited concomitant medications as described in the Protocol within 21 days of the Day 1 visit; this washout period does not apply to proton pump inhibitors, which can be taken up to 7 days before Day 1.
9. Chronic use of systemically administered immunosuppressive agents (eg, prednisone equivalent > 10 mg/day).
10. Known hypersensitivity to RBV, LDV, SOF, or formulation excipients.
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