Chronic Hepatitis CPhase 1/2NCT01272310
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.
A Phase 1/2 study testing Hydroxychloroquine (HCQ), Pegylated Interferon Alpha-2a (Peg-IFN alpha-2a) and Ribavirin in people with Chronic Hepatitis C, run by Sheba Medical Center.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Hepatitis C
- What is being tested?
- Hydroxychloroquine (HCQ), Pegylated Interferon Alpha-2a (Peg-IFN alpha-2a) and Ribavirin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Jul 2013
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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).
Show all 17Show fewer
- 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.
- Subject objects to the study protocol.
- Concurrent participation in any other clinical study within 30 days prior to enrollment.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Phase I/II, Open Clinical Trial to Assess 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 Subjects Who Failed to Respond Following a Course of Peg-IFN and RBV Therapy (SoC).
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.
Read the detailed description
This is a phase I/II, open clinical trial to assess the safety, tolerability and preliminary efficacy data of a fixed dose combination therapy of: HCQ, Peg-IFN alpha-2a and RBV in chronic hepatitis C genotype 1 infected subjects who failed to respond following a course of Peg-IFN and RBV Therapy (SoC). The study is a single center trial to be conducted at the Department of Gastroenterology \& Hepatology, at Sheba Medical Center, Tel Hashomer, Israel.
Overall, thirty six (36) patients will be recruited. All patients enrolled will have a documented history of chronic HCV disease and being non-responder on earlier Peg-IFN based treatment lasting for at least 12 consecutive weeks prior to study enrolment.
The expected duration of patient screening period prior to enrollment into this study is in-between six weeks (42 days) up to 2 days prior to the study enrollment day at visit 2 (verification of compliance with inclusion/exclusion criteria including clinical laboratory results). Eligible patients will be enrolled into the study and will be observed twice on the first week of the study, once a week during the initiation of the treatment period at weeks 2,3 and week 4, later during the treatment period once a month at weeks 8-48 and at two follow up visits post treatment to take place at week 60 and 72 (allowing a time window of ± 5 days for all visits).
- Conditions
- Chronic Hepatitis C
- Being tested
- Hydroxychloroquine (HCQ), Pegylated Interferon Alpha-2a (Peg-IFN alpha-2a) and Ribavirin
- Keywords
- Chronic Hepatitis C, Combination Therapy, Hydroxychloroquine, Pegylated Interferon Alpha-2a, Ribavirin, Chronic Hepatitis C Genotype 1 infected adult subjects
- Medical subject headings
- Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydroxychloroquine (HCQ), Pegylated Interferon Alpha-2a (Peg-IFN alpha-2a) and RibavirinBiological
Also called Copegus, Pegasys
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).
| Study group | Role | What they receive |
|---|---|---|
| Combination therapy | Experimental | Not described Receives: Biological: Hydroxychloroquine (HCQ), Pegylated Interferon Alpha-2a (Peg-IFN alpha-2a) and Ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in physical examination
Body system screaning
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Changes in HCV RNA levels, monitored along the study period. The efficacy of a HCQ-containing treatment regimen defined as the proportion of subjects with SVR i.e. undetectable HCV RNA <50 IU/ml) at 5 different time points: cEVR at 12 weeks, 4 weeks, 24 weeks, 48 weeks after treatment initiation and at 24 weeks after end of treatment (week 72).
Measured: at 4,12, 24, 48 and 72 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionJan 2012 (estimated)
- Study completionJul 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis CStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01272310
- Sponsor's protocol ID
- SHEBA-10-8033-YM-CTIL
- Other IDs
- HCQ-001-IL
- Status last verified
- Jan 2011
- First submitted
- 3 Jan 2011
- Last updated
- 7 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II, Open Clinical Trial to Assess 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 Subjects Who Failed to Respond Following a Course of Peg-IFN and RBV Therapy (SoC).
- ClinicalTrials.gov ID
- NCT01272310
- Acronym / sponsor ID
- SHEBA-10-8033-YM-CTIL
- Conditions
- Chronic Hepatitis C
- Keywords
- Chronic Hepatitis C, Combination Therapy, Hydroxychloroquine, Pegylated Interferon Alpha-2a, Ribavirin, Chronic Hepatitis C Genotype 1 infected adult subjects
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Jan 2011
- Primary completion
- Jan 2012 (estimated)
- Study completion
- Jul 2013 (estimated)
- First posted
- 7 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a phase I/II, open clinical trial to assess the safety, tolerability and preliminary efficacy data of a fixed dose combination therapy of: HCQ, Peg-IFN alpha-2a and RBV in chronic hepatitis C genotype 1 infected subjects who failed to respond following a course of Peg-IFN and RBV Therapy (SoC). The study is a single center trial to be conducted at the Department of Gastroenterology \& Hepatology, at Sheba Medical Center, Tel Hashomer, Israel.
Overall, thirty six (36) patients will be recruited. All patients enrolled will have a documented history of chronic HCV disease and being non-responder on earlier Peg-IFN based treatment lasting for at least 12 consecutive weeks prior to study enrolment.
The expected duration of patient screening period prior to enrollment into this study is in-between six weeks (42 days) up to 2 days prior to the study enrollment day at visit 2 (verification of compliance with inclusion/exclusion criteria including clinical laboratory results). Eligible patients will be enrolled into the study and will be observed twice on the first week of the study, once a week during the initiation of the treatment period at weeks 2,3 and week 4, later during the treatment period once a month at weeks 8-48 and at two follow up visits post treatment to take place at week 60 and 72 (allowing a time window of ± 5 days for all visits).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combination therapy | Experimental | Biological: Hydroxychloroquine (HCQ), Pegylated Interferon Alpha-2a (Peg-IFN alpha-2a) and Ribavirin |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydroxychloroquine (HCQ), Pegylated Interferon Alpha-2a (Peg-IFN alpha-2a) and RibavirinAlso: Copegus, PegasysHCQ 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). | Biological | Combination therapy |
Primary outcome
Change from baseline in physical examination
Time frame: 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
Body system screaning
Change from baseline in vital Signs
Time frame: 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
Heart Rate, Blood Presure, Respiratory Rate , Body temperature
Change from baseline in clinical laboratory parameters
Time frame: 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
Hematology, Blood Chemistry, Coagulation parameters, Urinalysis
Change from baseline in adverse events
Time frame: 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
All observed and or reported adverse events
1 secondary outcome
HCV RNA level
Time frame: at 4,12, 24, 48 and 72 weeks after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2011.
Related trials for Chronic Hepatitis C
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
Active, not recruitingPhase 4
Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
Hepatitis C, Chronic, Pregnancy; Infection
Enrolling by invitationObservational study
Comparative Autoantibody and Immunologic Cell Marker Study
Autoimmune Diseases, Lupus Erythematosus, Systemic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Hydroxychloroquine (HCQ), Pegylated Interferon Alpha-2a (Peg-IFN alpha-2a) and Ribavirin in people with Chronic Hepatitis C, run by Sheba Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yaakov Maor, Dr (97235302906, yaakov.maor@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in physical examination (time frame: 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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2011.