Clinical Trial to Assess Safety and Efficacy of Combination Therapy: Hydroxychloroquine, Pegylated Interferon Alpha-2a and Ribavirin in Chronic Hepatitis C Subjects Non-responders to the Standard of Care Therapy.

NCT01272310 | Unknown Phase 1

• 2 other identifiers: SHEBA-10-8033-YM-CTILHCQ-001-IL
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study is aimed to investigate the safety, tolerability and efficacy of a fixed dose combination therapy of: Hydroxychloroquine (HCQ), Pegylated Interferon Alpha-2a (PEG-IFN alpha-2a) and Ribavirin (RBV) in Chronic Hepatitis C Genotype 1 Infected adult subjects who failed to respond following a course of PEG-IFN and RBV Therapy.

Conditions

Chronic Hepatitis C

Keywords

Chronic Hepatitis C; Combination Therapy; Hydroxychloroquine; Pegylated Interferon Alpha-2a; Ribavirin; Chronic Hepatitis C Genotype 1 infected adult subjects

Outcome Measures

Primary Outcomes (4)

• Change from baseline in physical examination

  Body system screaning

  Twice on study first week , once a week during treatment initiation at weeks 2,3 ,4, later during treatment period once a month at weeks 8-48 and at weeks 60 and 72 follow up visits post treatment

• Change from baseline in vital Signs

  Heart Rate, Blood Presure, Respiratory Rate , Body temperature

  Twice on study first week , once a week during treatment initiation at weeks 2,3 ,4, later during treatment period once a month at weeks 8-48 and at weeks 60 and 72 follow up visits post treatment

• Change from baseline in clinical laboratory parameters

  Hematology, Blood Chemistry, Coagulation parameters, Urinalysis

  Twice on study first week , once a week during treatment initiation at weeks 2,3 ,4, later during treatment period once a month at weeks 8-48 and at weeks 60 and 72 follow up visits post treatment

• Change from baseline in adverse events

  All observed and or reported adverse events

  Twice on study first week , once a week during treatment initiation at weeks 2,3 ,4, later during treatment period once a month at weeks 8-48 and at weeks 60 and 72 follow up visits post treatment

Secondary Outcomes (1)

• HCV RNA level

  at 4,12, 24, 48 and 72 weeks after treatment

Study Arms (1)

Combination therapy

EXPERIMENTAL

Biological: Hydroxychloroquine (HCQ), Pegylated Interferon Alpha-2a (Peg-IFN alpha-2a) and Ribavirin

Interventions

Hydroxychloroquine (HCQ), Pegylated Interferon Alpha-2a (Peg-IFN alpha-2a) and Ribavirin BIOLOGICAL

HCQ will be taken daily as an oral tablet of 200 mg b.i.d. Pegylated Interferon Alpha-2a - (180 µg) will be administered as weekly subcutaneous (s.c.) injections of 0.5 ml. Ribavirin - will be taken daily based on the patient body weight. If body weight is \< 75 kg, the total daily dose of Copegus® is 1000 mg, administered as 400 mg (2 tablets of 200 mg, morning intake) and 600 mg (3 tablets of 200 mg, evening intake). If body weight is \>= 75 kg, the total daily dose is 1200 mg administered as twice 600 mg (3 tablets of 200 mg per intake, morning and evening).

Also known as: Copegus, Pegasys

Combination therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females between 18 and 70 years old.
• Subjects diagnosed to have positive HCV antibodies using a third generation test.
• Subject is diagnosed to have detectable HCV RNA by PCR.
• Liver biopsy or FibroTest showing a METAVIR score ≥F2 and/or ≥A2.
• Subject diagnosed to have compensated liver disease.
• Subject is non-responder (null or partial) on prior Peg-IFN and RBV based treatment lasting for at least 12 consecutive weeks.
• Treatment not discontinued due to intolerability to Peg-IFN or RBV.
• Subjects able to comprehend and give informed consent for participation in this study.
• Subject is willing to be treated and commit to all visits.

You may not qualify if:

• Anti HCV therapy contraindications.
• Subject is identified as a relapser on prior Peg-IFN and RBV based treatment.
• Hypersensitivity to one of the three drugs (HCQ, Peg-IFN, RBV).
• Patient has Anaemia,neutropenia, thrombocytopenia, elevated bilirubin levels, elevated ALT and/or AST, or elevated creatinin and INR greater than 1.5.
• Concomitant liver disease other than hepatitis C: chronic hepatitis B, alcoholic liver disease, autoimmune hepatitis, Wilson's disease, hemochromatosis, alpha-1 antitrypsin deficiency.
• Decompensated cirrhosis (Child Pugh \>A).
• Clinical evidence for hepatocellular carcinoma.
• Human immunodeficiency virus co-infection.
• Major uncontrolled psychiatric illness. Minor or situational depressions are allowed.
• Active elicit drug or alcohol abuse.
• Serious co-morbid conditions as: heart failure, significant coronary heart disease, chronic obstructive pulmonary disease, renal insufficiency, poorly controlled diabetes, autoimmune disorders, and malignant diseases in the previous 5 years.
• Immunosuppressive treatment including corticosteroids,
• Untreated or uncontrolled or thyroid disease.
• Solid transplant organ (renal, heart, or lung).
• Pregnancy or unwillingness to practice double contraception or abstinence by the subject of childbearing potential or partner.

Sponsors & Collaborators

• Sheba Medical Center: lead

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

Hydroxychloroquine; peginterferon alfa-2a; Ribavirin

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Yaakov Maor, Dr

CONTACT

97235302906; yaakov.maor@sheba.health.gov.il

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: January 3, 2011
• First Posted: January 7, 2011
• Study Start: January 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: July 1, 2013
• Last Updated: January 7, 2011

Record last verified: 2011-01