Efficacy, Safety and Tolerability of Ribavirin Monotherapy Followed by Combined Treatment With Ribavirin and Hydroxychloroquine in Patients Infected With Hepatitis C

NCT01833845 | Terminated Phase 1 Results

• 1 other identifier: BL-8020.01
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 2

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 administration of RBV monotherapy for a period of 8 weeks and Treatment Period 2 involves administration of up to 16 weeks combination therapy with RBV plus HCQ.

Conditions

Hepatitis C

Keywords

HCV; Hepatitis C; Hep-C

Outcome Measures

Primary Outcomes (2)

• Efficacy

  To evaluate the effect of 16-week combination therapy with RBV plus HCQ following 8 weeks of monotherapy with RBV in HCV-infected patients.

  24 weeks

• Safety: Number of Participants With Adverse Events

  Safety was assessed throughout study by collection of adverse event and concomitant medication data, and routine monitoring of lab safety tests, physical exams, ophthalmic examination, vital signs and 12 lead electrocardiograms.

  all 24 weeks

Secondary Outcomes (1)

• Efficacy

  8 weeks

Study Arms (1)

Ribavirin+HCQ

EXPERIMENTAL

Administration of RBV monotherapy for a period of 8 weeks following administration of up to 16 weeks combination therapy with ribavirin(RBV) plus Hydroxychloroquine(HCQ).

Drug: Ribavirin; Drug: Hydroxychloroquine

Interventions

Ribavirin DRUG

weight-based doses (1000 mg/day administered BID \[twice daily\] for subjects ≤ 75 kg and 1200 mg/day administered BID for subjects \> 75 kg). Those subjects receiving 1000 mg/day RBV will take 2 tablets of 200 mg/tablet in the morning and 3 tablets in the evening, and those subjects receiving 1200 mg/day RBV will take 3 tablets morning and evening.

Also known as: RBV

Ribavirin+HCQ

Hydroxychloroquine DRUG

subjects will receive HCQ 575 mg administered as a single tablet once daily (QD)

Also known as: HCQ

Ribavirin+HCQ

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• BioLineRx, Ltd.: lead

Study Sites (2)

Hospital St. Joseph

Marseille, France

Location

Cochin Hospital

Paris, France

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

Ribavirin; Hydroxychloroquine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Arnon Aharon
• Organization: BioLineRx LTD

arnona@biolinerx.com

972-2-548-9100

Study Officials

• Stanislas Pol, MD

  Cochin Hospital

  PRINCIPAL INVESTIGATOR

• Marc Bourliere, MD

  S.Joseph Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2013
• First Posted: April 17, 2013
• Study Start: April 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: August 28, 2014
• Results First Posted: August 28, 2014

Record last verified: 2014-08

Locations

FR (2)