Hepatitis CPhase 4NCT00560690
The Effect of Adding Metformin to the Treatment of Hepatitis C
A Phase 4 study testing Metformin, pegylated interferon and Ribavirin in people with Hepatitis C, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial summary
Insulin resistance is known to adversely effect viral response to treatment in hepatitis C patients We are aiming to study the effect of an insulin sensitizer, metformin, in viral response of hepatitis C to treatment with pegylated interferon and ribavirin in a double blind randomized controlled trial Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Metformin, pegylated interferon and Ribavirin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteIran
- Study dates
- Dec 2007to Dec 2010
- 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 15 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- chronic hepatitis C
- Iranian nationality
- Treatment naive
Who cannot join
- cirrhosis
- diabetes mellitus
- HBV/HIV coinfection
- contraindications of metformin, interferon, ribavirin
- severe medical conditions (e.g. CHF, CRF, psychosis, ...)
- not consenting
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect and Safety of Adding Metformin to the Standard Treatment of Hepatitis C on Sustained Viral Response
Insulin resistance is known to adversely effect viral response to treatment in hepatitis C patients
We are aiming to study the effect of an insulin sensitizer, metformin, in viral response of hepatitis C to treatment with pegylated interferon and ribavirin in a double blind randomized controlled trial
Read the detailed description
Subjects with hepatitis C will be randomized to receive standard treatment with or without metformin. The results will be compared.
- Conditions
- Hepatitis C
- Keywords
- Hepatitis C, metformin, Insulin Resistance
- Medical subject headings
- Hepatitis C, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
500 mg oral three times a day for 6 months
pegylated interferonDrug
180 micrograms, or 1.5 micrograms/kg body weight weekly SQ injection for 6 or 12 months depending on genotype
RibavirinDrug
800-1200 mg PO given in 2 divided doses for 6 to 12 months depending on weight and genotype
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | standard treatment with pegylated interferon and ribavirin + placebo Receives: Drug: pegylated interferon; Drug: Ribavirin |
| Metformin | Experimental | standard treatment with pegylated interferon and ribavirin + metformin Receives: Drug: Metformin; Drug: pegylated interferon; Drug: Ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained viral response, defined as undetectable virus RNA 6 months after end of treatment
Measured: 6 months after end of treatment
Secondary outcomes (3)
adverse effects leading to discontinuation of treatment
Measured: anytime during the study
Rapid viral response, defined as undetectable viral RNA one month after start of treatment
Measured: one month after start of treatment
Early viral response, defined as undetectable viral RNA or 2 log drop in viral count three month after start of treatment
Measured: three months after start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2007 (estimated)
- Study startDec 2007
- Primary completionSep 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies 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
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shahin Merat, Tehran University of Medical Sciences
- Investigators
- Shahin Merat, MD, Principal investigator, Digestive Disease Research Center, Medical Sciences / University of TehranReza Malekzadeh, MD, Study chair, Digestive Disease Research Center, Medical Sciences / University of Tehran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00560690
- Sponsor's protocol ID
- 83/53
- Status last verified
- Apr 2015
- First submitted
- 19 Nov 2007
- Last updated
- 6 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect and Safety of Adding Metformin to the Standard Treatment of Hepatitis C on Sustained Viral Response
- ClinicalTrials.gov ID
- NCT00560690
- Acronym / sponsor ID
- 83/53
- Conditions
- Hepatitis C
- Keywords
- Hepatitis C, metformin, Insulin Resistance
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Sep 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 20 Nov 2007 (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.
Insulin resistance is known to adversely effect viral response to treatment in hepatitis C patients
We are aiming to study the effect of an insulin sensitizer, metformin, in viral response of hepatitis C to treatment with pegylated interferon and ribavirin in a double blind randomized controlled trial
Detailed description
Subjects with hepatitis C will be randomized to receive standard treatment with or without metformin. The results will be compared.
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 |
|---|---|---|
| Placebo | Placebo comparator | Drug: pegylated interferon, Drug: Ribavirinstandard treatment with pegylated interferon and ribavirin + placebo |
| Metformin | Experimental | Drug: Metformin, Drug: pegylated interferon, Drug: Ribavirinstandard treatment with pegylated interferon and ribavirin + metformin |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- chronic hepatitis C
- Iranian nationality
- Treatment naive
Key exclusion criteria (6 listed)
- cirrhosis
- diabetes mellitus
- HBV/HIV coinfection
- contraindications of metformin, interferon, ribavirin
- severe medical conditions (e.g. CHF, CRF, psychosis, ...)
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 |
|---|---|---|
| Metformin500 mg oral three times a day for 6 months | Drug | Metformin |
| pegylated interferon180 micrograms, or 1.5 micrograms/kg body weight weekly SQ injection for 6 or 12 months depending on genotype | Drug | Metformin, Placebo |
| Ribavirin800-1200 mg PO given in 2 divided doses for 6 to 12 months depending on weight and genotype | Drug | Metformin, Placebo |
Primary outcome
Sustained viral response, defined as undetectable virus RNA 6 months after end of treatment
Time frame: 6 months after end of treatment
3 secondary outcomes
adverse effects leading to discontinuation of treatment
Time frame: anytime during the study
Rapid viral response, defined as undetectable viral RNA one month after start of treatment
Time frame: one month after start of treatment
Early viral response, defined as undetectable viral RNA or 2 log drop in viral count three month after start of treatment
Time frame: three months after start of treatment
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 6 Apr 2015.
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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.
Shahin Merat, MD principal investigator
Digestive Disease Research Center, Medical Sciences / University of Tehran
Reza Malekzadeh, MD study chair
Digestive Disease Research Center, Medical Sciences / University of Tehran
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 Metformin, pegylated interferon and Ribavirin in people with Hepatitis C, run by Tehran 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 3 inclusion and 6 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 6 Apr 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. Some participants in this study may receive a placebo. 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?
Sustained viral response, defined as undetectable virus RNA 6 months after end of treatment (time frame: 6 months after end of treatment). 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 6 Apr 2015.