Status:
TERMINATED
Efficacy, Safety and Tolerability of Ribavirin Monotherapy Followed by Combined Treatment With Ribavirin and Hydroxychloroquine in Patients Infected With Hepatitis C
Lead Sponsor:
BioLineRx, Ltd.
Conditions:
Hepatitis C
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Proof-of Concept, Open-Label, Two-Stage Study without Direct Individual Benefit The proposed study design consists of two treatment periods and one treatment arm. Treatment Period 1 involves the admin...
Detailed Description
Patients who provide their informed consent and conform to all the inclusion and none of the exclusion criteria will be enrolled into the study and will receive RBV monotherapy for 8 weeks. Subjects w...
Eligibility Criteria
Inclusion
- Male or female, age ≥ 18.
- Subjects diagnosed to have positive HCV antibodies.
- Subject is diagnosed to have detectable HCV RNA by PCR.
- FibroTest or FibroScan or liver biopsy showing a METAVIR score ≤ F2 and/or
- ≤ A2 within 2 years of the screening visit.
- Subject is a non-responder (null or partial ) OR relapsed following prior Peg-IFN and RBV based treatment lasting for at least 12 consecutive weeks.
- Platelet count greater than or equal to 100,000 cells/mm3.
- Absolute neutrophil count (ANC) greater than or equal to 1500 cells/mm3.
- Subjects able to comprehend and give written informed consent for participation in this study.
- Women of childbearing potential and all men must agree to use an approved form of contraception (e.g., oral, transdermal patch, implanted contraceptives, intrauterine device, diaphragm, condom, abstinence or surgical sterility) prior to study entry and for the duration of study participation through 7 months after the last dose of study medication. Confirmation that the female patient is not pregnant must be established by a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women.
- Subject is willing to be treated and commit to all visits
Exclusion
- Contraindication or hypersensitivity to one of the study drugs (HCQ or RBV).
- Patient has anemia (male \<13 g/dL; female \<12 g/dL), elevated ALT and/or AST \>10 x ULN or elevated creatinine (\>1.5 mg/dL).
- Concomitant liver disease other than hepatitis C: alcoholic liver disease, autoimmune hepatitis, Wilson's disease, hemochromatosis, alpha-1 antitrypsin deficiency.
- Decompensated cirrhosis (Child Pugh \>A).
- Ongoing hepatocellular carcinoma (suggestive imaging study or alpha-fetoprotein (AFP) \>50 ng/mL).
- Hepatitis B or Human Immunodeficiency Virus (HIV1 or HIV2) co-infection.
- Clinically relevant ECG abnormalities on screening or baseline 12-lead ECG, e.g.,
- QTc interval (QTcB or QTcF \> 450 ms in males and \> 470 ms in females);
- Notable resting bradycardia (HR \< 40 bpm);
- Any other significant abnormality suggestive of structural heart disease.
- Family history of congenital long QT syndrome.
- Clinically significant abnormalities on ophthalmic examination.
- Major uncontrolled psychiatric illness. Minor or situational depressions are allowed.
- History of hemoglobinopathy (e.g., thalassemia) or any other cause of or tendency to hemolysis (e.g., G-6-PD deficiency).
- Active illicit drug or alcohol abuse.
- Serious co-morbid conditions such as: heart failure, significant coronary heart disease, chronic obstructive pulmonary disease, poorly controlled diabetes, autoimmune disorders and any malignant diseases (except in situ carcinomas or basal cell carcinoma) in the previous 5 years.
- Patients with chronic renal insufficiency, creatinine clearance \< 50 mL/minute and/or undergoing haemodialysis.
- Patients with porphyria or psoriasis.
- Ongoing concomitant treatment with azathioprine, digoxin or medications known to prolong QT interval.
- History of organ transplantation.
- Pregnancy, breast-feeding or unwillingness to practice double contraception or abstinence by the subject of childbearing potential or partner.
- Concurrent participation in any other clinical study or within 180 days 20.Patients with inability to communicate well with the Investigators and staff (i.e., language problem, poor mental development or impaired cerebral function) or any other condition that in the opinion of the Investigator will place the patient at risk or prevent protocol compliance.
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Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT01833845
Start Date
April 1 2013
End Date
April 1 2014
Last Update
August 28 2014
Active Locations (2)
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1
Hospital St. Joseph
Marseille, France
2
Cochin Hospital
Paris, France