Chronic Hepatitis cPhase 2/3NCT01664845
Effects of Metformin, Pegylated Interferon Alpha and Ribavirin for Chronic Hepatitis C With Insulin Resistance
A Phase 2/3 study testing metformin, pegylated-IFN and ribavirin in people with Chronic Hepatitis c and Insulin Resistance, run by Kaohsiung Veterans General Hospital. at 1 site in Taiwan.
Trial summary
The aim of the study is to investigate the treatment response of metformin, Peg-IFN and ribavirin combination therapy for chronic hepatitis C virus (HCV). Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Chronic Hepatitis c, Insulin Resistance
- What is being tested?
- metformin, pegylated-IFN and ribavirin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2012to Aug 2014
- Phase
- Phase 2/3
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HCV RNA (+) and ALT > 40 U/L
- Compensated liver
- HOMA-IR > 2
Who cannot join
- neutrophil <1500/mm3
- male: Hb < 13 g/dl, female: Hb < 12 g/dl
- platelet < 80,000 /mm3
- Cr > 2.5 mg/dl
- Alcohol use > 20 gm per day
- uncontrolled depression, thyroid disease, autoimmune disease
Show all 11Show fewer
- Pregnancy
- Hepatocellular carcinoma
- allergy to interferon or ribavirin
- Diabetes
- HBV/HIV co-infection
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Kaohsiung Veterans General Hospital
Kaohsiung, Taiwan, 813
Wei-Lun Tsai, MD, 886-7-3422121 ext. 2075, tsaiwl@yahoo.com.tw
Wei-Lun Tsai, MD
About this study
The aim of the study is to investigate the treatment response of metformin, Peg-IFN and ribavirin combination therapy for chronic hepatitis C virus (HCV).
Read the detailed description
Current standard of treatment for HCV with pegylated interferon(Peg-IFN)-alpha and ribavirin can achieve sustained virological response (SVR) in only 60-90% of patients. Insulin resistance is an important factor of non-response to combination therapy. Metformin is a insulin sensitizer and can effectively reduce insulin resistance. The aim of the study is to investigate the treatment response of metformin, Peg-IFN and ribavirin combination therapy for chronic HCV.
- Conditions
- Chronic Hepatitis c, Insulin Resistance
- Keywords
- hepatitis c, metformin, pegylated interferon
- Medical subject headings
- Hepatitis C, Chronic, Insulin Resistance, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
metforminDrug
Also called glucophage
metformin 500mg tid
pegylated-IFNDrug
Also called pegasys
pegasys 180 mcg qw
ribavirinDrug
ribavirin 800-1200 mg qd according to BW
| Study group | Role | What they receive |
|---|---|---|
| metformin, pegylated-IFN, ribavirin | Active comparator | metformin,pegylated-IFN and ribavirin Receives: Drug: metformin; Drug: pegylated-IFN; Drug: ribavirin |
| Pegylated-IFN and ribavirin | Placebo comparator | pegylated -IFN and ribavirin Receives: Drug: pegylated-IFN; Drug: ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
sustained virological response
HCV RNA negative 24 weeks after treatment is stopped
Measured: 24 weeks after treatment is stopped
Secondary outcomes (1)
change of HOMA-IR
Check Serial change HOMA-IR at baseline, 4 weeks and 12 weeks after treatment
Measured: Serial change of HOMA-IR at baseline, 4 weeks and 12 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 posted14 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionAug 2014 (estimated)
- Study completionAug 2014 (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.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Veterans General Hospital.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei-Lun Tsai, Kaohsiung Veterans General Hospital.
- Investigators
- Wei-Lun Tsai, MD, Principal investigator, Department of Gastroenterology, Kaohsoung Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01664845
- Sponsor's protocol ID
- VGHKS12-CT3-16
- Status last verified
- Aug 2012
- First submitted
- 10 Aug 2012
- Last updated
- 14 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Metformin, Pegylated Interferon Alpha and Ribavirin for Chronic Hepatitis C With Insulin Resistance
- ClinicalTrials.gov ID
- NCT01664845
- Acronym / sponsor ID
- VGHKS12-CT3-16
- Conditions
- Chronic Hepatitis c, Insulin Resistance
- Keywords
- hepatitis c, metformin, pegylated interferon
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Kaohsiung Veterans General Hospital.University, hospital or other
- Study start
- Aug 2012
- Primary completion
- Aug 2014 (estimated)
- Study completion
- Aug 2014 (estimated)
- First posted
- 14 Aug 2012 (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 aim of the study is to investigate the treatment response of metformin, Peg-IFN and ribavirin combination therapy for chronic hepatitis C virus (HCV).
Detailed description
Current standard of treatment for HCV with pegylated interferon(Peg-IFN)-alpha and ribavirin can achieve sustained virological response (SVR) in only 60-90% of patients. Insulin resistance is an important factor of non-response to combination therapy. Metformin is a insulin sensitizer and can effectively reduce insulin resistance. The aim of the study is to investigate the treatment response of metformin, Peg-IFN and ribavirin combination therapy for chronic HCV.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| metformin, pegylated-IFN, ribavirin | Active comparator | Drug: metformin, Drug: pegylated-IFN, Drug: ribavirinmetformin,pegylated-IFN and ribavirin |
| Pegylated-IFN and ribavirin | Placebo comparator | Drug: pegylated-IFN, Drug: ribavirinpegylated -IFN and ribavirin |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- HCV RNA (+) and ALT > 40 U/L
- Compensated liver
- HOMA-IR > 2
Key exclusion criteria (11 listed)
- neutrophil <1500/mm3
- male: Hb < 13 g/dl, female: Hb < 12 g/dl
- platelet < 80,000 /mm3
- Cr > 2.5 mg/dl
- Alcohol use > 20 gm per day
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 |
|---|---|---|
| metforminAlso: glucophagemetformin 500mg tid | Drug | metformin, pegylated-IFN, ribavirin |
| pegylated-IFNAlso: pegasyspegasys 180 mcg qw | Drug | Pegylated-IFN and ribavirin, metformin, pegylated-IFN, ribavirin |
| ribavirinribavirin 800-1200 mg qd according to BW | Drug | Pegylated-IFN and ribavirin, metformin, pegylated-IFN, ribavirin |
Primary outcome
sustained virological response
Time frame: 24 weeks after treatment is stopped
HCV RNA negative 24 weeks after treatment is stopped
1 secondary outcome
change of HOMA-IR
Time frame: Serial change of HOMA-IR at baseline, 4 weeks and 12 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 14 Aug 2012.
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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.
Wei-Lun Tsai, MD principal investigator
Department of Gastroenterology, Kaohsoung Veterans General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing metformin, pegylated-IFN and ribavirin in people with Chronic Hepatitis c and Insulin Resistance, run by Kaohsiung Veterans General Hospital. at 1 site in Taiwan.
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 11 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 14 Aug 2012. 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 Taiwan. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Wei-Lun Tsai, MD (886-7-3422121 ext. 2075, tsaiwl@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sustained virological response (time frame: 24 weeks after treatment is stopped). 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 14 Aug 2012.