Hepatitis C VirusPhase 4NCT02058173
"Pharmacoepidemiological Evaluation of Autophagy Inhibition in Treatment of HCV Patients Resistant to Standard Therapy. Pilot Study"
A Phase 4 study testing Chloroquine in people with Hepatitis C Virus, run by Shiraz University of Medical Sciences at 1 site in Iran.
Trial summary
The purpose of this study is to assess the efficacy of Chloroquine comparing with placebo for treatment of non- response HCV patients.. In this triple blind pilot study, 20 patients with confirmed chronic hepatitis C will be randomize into treatment group (Chloroquine 150 mg daily, for 8 weeks) or control group… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hepatitis C Virus
- What is being tested?
- Chloroquine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteIran
- Study dates
- Jan 2014to Jun 2014
- Phase
- Phase 4
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients who failed to achieve a decline of 2 log HCV RNA IU/ml after 12 weeks of treatment
- who never achieved undetectable HCV RNA during treatment of a minimum duration of 24 weeks
Who cannot join
- Receiving anti neoplasm, anti viral or immunomedulator drugs during 6 months prior to study
- coinfection with Hepatitis A,C,D viruses or HIV
- Severe dysfunction of liver and kidney
- pregnancy
- breast feeding
- refusing to give informed consent
- active Alcohol user
- presence of decompensate cirrhosis
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to assess the efficacy of Chloroquine comparing with placebo for treatment of non- response HCV patients.. In this triple blind pilot study, 20 patients with confirmed chronic hepatitis C will be randomize into treatment group (Chloroquine 150 mg daily, for 8 weeks) or control group (placebo once daily, for 8 weeks). Patients who have receiving anti neoplastic, anti viral or Immunomedullator drugs during 6 months prior to study, have co-infection Hepatitis A,C,D or HIV, severe liver or renal dysfunction, are pregnant or breast fed, or refuse to sign informed consent will be excluded.. At the end of therapy (12 weeks) and at baseline, first, second and third month after receiving drug and placebo HCV Virus load, CBC LFT and biochemical parameters will be evaluated and compared between groups.
- Conditions
- Hepatitis C Virus
- Being tested
- 150 mg/daily chloroquine compare to placebo for 12 week, Chloroquine, placebo
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
150 mg/daily chloroquine compare to placebo for 12 weekDrug
ChloroquineDrug
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| chloroquine | Experimental | 150 mg chloroquine and lacebo , one tablet daily for 2 month Receives: Drug: 150 mg/daily chloroquine compare to placebo for 12 week; Drug: Chloroquine |
| placebo | Experimental | 150 mg chloroquine and lacebo , one tablet daily for 2 month Receives: Drug: 150 mg/daily chloroquine compare to placebo for 12 week; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Loss of HCV RNA at end of treatment which is 8 weeks
Measured: march 2014
Secondary outcomes (1)
Two log decrease in HCV RNA at the end of treatment
Measured: july 2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2014 (estimated)
- Study startJan 2014
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis C VirusStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shiraz University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Payam Peymani, Shiraz University of Medical Sciences
- Investigators
- Kamran B Lankarani, M.D, Study chair, Health policy research center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02058173
- Sponsor's protocol ID
- HP7-92
- Other IDs
- HP7-92
- Status last verified
- Oct 2015
- First submitted
- 5 Feb 2014
- Last updated
- 20 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Pharmacoepidemiological Evaluation of Autophagy Inhibition in Treatment of HCV Patients Resistant to Standard Therapy. Pilot Study"
- ClinicalTrials.gov ID
- NCT02058173
- Acronym / sponsor ID
- HP7-92
- Conditions
- Hepatitis C Virus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Shiraz University of Medical SciencesUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 7 Feb 2014 (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 purpose of this study is to assess the efficacy of Chloroquine comparing with placebo for treatment of non- response HCV patients.. In this triple blind pilot study, 20 patients with confirmed chronic hepatitis C will be randomize into treatment group (Chloroquine 150 mg daily, for 8 weeks) or control group (placebo once daily, for 8 weeks). Patients who have receiving anti neoplastic, anti viral or Immunomedullator drugs during 6 months prior to study, have co-infection Hepatitis A,C,D or HIV, severe liver or renal dysfunction, are pregnant or breast fed, or refuse to sign informed consent will be excluded.. At the end of therapy (12 weeks) and at baseline, first, second and third month after receiving drug and placebo HCV Virus load, CBC LFT and biochemical parameters will be evaluated and compared between groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| chloroquine | Experimental | Drug: 150 mg/daily chloroquine compare to placebo for 12 week, Drug: Chloroquine150 mg chloroquine and lacebo , one tablet daily for 2 month |
| placebo | Experimental | Drug: 150 mg/daily chloroquine compare to placebo for 12 week, Drug: placebo150 mg chloroquine and lacebo , one tablet daily for 2 month |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- patients who failed to achieve a decline of 2 log HCV RNA IU/ml after 12 weeks of treatment
- who never achieved undetectable HCV RNA during treatment of a minimum duration of 24 weeks
Key exclusion criteria (8 listed)
- Receiving anti neoplasm, anti viral or immunomedulator drugs during 6 months prior to study
- coinfection with Hepatitis A,C,D viruses or HIV
- Severe dysfunction of liver and kidney
- pregnancy
- breast feeding
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 |
|---|---|---|
| 150 mg/daily chloroquine compare to placebo for 12 week | Drug | chloroquine, placebo |
| Chloroquine | Drug | chloroquine |
| placebo | Drug | placebo |
Primary outcome
Loss of HCV RNA at end of treatment which is 8 weeks
Time frame: march 2014
1 secondary outcome
Two log decrease in HCV RNA at the end of treatment
Time frame: july 2014
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2015.
Related trials for Hepatitis C Virus
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Not yet recruitingObservational study
Elimination of Hepatitis C Virus Among Users of Substances
Hepatitis C in Substance Users
Not yet recruiting
Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use
HCV Infection
Not yet recruiting
Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
HCV Infection
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
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.
Kamran B Lankarani, M.D study chair
Health policy research center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Chloroquine in people with Hepatitis C Virus, run by Shiraz University of Medical Sciences at 1 site in Iran.
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 2 inclusion and 8 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: finished, as of the sponsor's last update on 20 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Loss of HCV RNA at end of treatment which is 8 weeks (time frame: march 2014). 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 20 Oct 2015.