Chronic Hepatitis CPhase 4TRIC-1NCT00546442
Treatment Insulin Resistence in HCV G-1 Patient
A Phase 4 study testing Metformine in people with Chronic Hepatitis C, run by Valme University Hospital at 19 sites in Spain.
Trial summary
To evaluate the effect of treatment of insulin resistance in the response of chronic hepatitis C treatment, mesure as HCV-RNA negative at week 72. 4.3.2 Objetivos secundarios To evaluate the efficacy and safety of treatment with metformine to erradicate the insulin resistance of patients with chornic hepatitis C… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Hepatitis C
- What is being tested?
- Metformine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 19 sitesSpain
- Study dates
- May 2006to Jan 2007
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients with 18 years of age or more
- Serum HCV-RNA quantifiable
- Genotype 1
- Liver disease compensated
- HOMA-IR > 2
- Treatment with Peginterferon alfa-2a + Ribavirin.
- Negative urine or blood pregnancy test (for women of childbearing potential)
- All fertile males and females must be using effective contraception
Who cannot join
- Liver chirrosis
- Diabetes
- Women with ongoing pregnancy or breast feeding
- HIV positive
- Patients who during 6 months previous to treatment loss more of 10% of weight
- Therapy with anti-neoplasic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) 6 months prior to the first dose of study drug
Show all 21Show fewer
- Any investigational drug 6 weeks prior to the first dose of study drug
- History or other evidence of a medical condition associated with chronic liver disease other than HCV
- Carcinoma hepatocellular
- History or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease
- Neutrophil count <1500 cells/mm3 or platelet count <90,000 cells/mm3 at screening
- Hgb <12 g/dL in women or <13 g/dL in men or any patient for whom anemia would be medically problematic
- History of significant cardiac disease that could be worsened by acute anemia
- Serum creatinine level >1.5 times the upper limit of normal at screening
- History of severe psychiatric disease, especially depression. Severe psychiatric disease is defined as treatment with an antidepressant medication or a major tranquilizer at therapeutic doses for major depression or psychosis, respectively, for at least 3 months at any previous time or any history of the following: a suicidal attempt, hospitalization for psychiatric disease, or a period of disability due to a psychiatric disease
- History of a severe seizure disorder or current anticonvulsant use
- History of immunologically mediated disease, chronic pulmonary disease associated with functional limitation, severe cardiac disease, major organ transplantation or other evidence of severe illness, malignancy, or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
- History of thyroid disease poorly controlled on prescribed medications, elevated thyroid stimulating hormone (TSH) concentrations with elevation of antibodies to thyroid peroxidase and any clinical manifestations of thyroid disease
- Evidence of severe retinopathy (e.g. CMV retinitis, macula degeneration)
- Evidence of drug abuse (including excessive alcohol consumption) within one year of study entry
- Inability or unwillingness to provide informed consent or abide by the requirements of the study
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
Spain19 sites
Fundación Hospital de Alcorcón
Alcorcón, Madrid, 28922
Hospital Germans Trias i Pujol
Badalona, Barcelona, 08916
Hospital del Mar
Barcelona, Barcelona, 08003
Hospital General de Ciudad Real
Ciudad Real, Ciudad Real, 13005
Hospital Reina Sofía
Córdoba, Córdoba, 14004
Hospital de Donostia
Donostia / San Sebastian, Guipuzcoa, 20014
Hospital Clínico Universitario San Cecilio
Granada, Granada, 18003
Hospital Virgen de las Nieves
Granada, Granada, 18004
Hospital de Leon
León, Leon, 24071
Hospital de la Princesa
Madrid, Madrid, 28006
Hospital Gregorio Marañón
Madrid, Madrid, 28007
Hospital Carlos III
Madrid, Madrid, 28029
Hospital Puerta de Hierro
Madrid, Madrid, 28035
Hospital La Paz
Madrid, Madrid, 28046
Hospital Universitario Virgen de la Victoria
Málaga, Málaga, 29010
Hospital Parc Taulí
Sabadell, Barcelona, 08208
Hospital Virgen Macarena
Seville, Sevilla, 41009
Hospital Universitario de Valme
Seville, Sevilla, 41014
Hospital General Universitario
Valencia, Valencia, 46014
About this study
Official title: Effect of Treatment of Insulin Resistance in Patients With Chronic Hepatitis C Genotype 1 Treated With Peginterferon Alfa-2a in Combination With Ribavirin in Current Clinical Practice
To evaluate the effect of treatment of insulin resistance in the response of chronic hepatitis C treatment, mesure as HCV-RNA negative at week 72.
4.3.2 Objetivos secundarios To evaluate the efficacy and safety of treatment with metformine to erradicate the insulin resistance of patients with chornic hepatitis C genotype 1 measure as HOMA-IR < 2.
Read the detailed description
Differents studies show that infection by virus hepatitis C have a relevant rol in the development of insulin resistance. The insulin resistence is associated with a progression of fibrosis and the development of steatosis. The insulin resistence is frecuently associated with very difficult to cure patients as cirrhotics, afro-american patients, overweight patients and co-infected HCV-HIV patients. Recently is repported that sustained virological (SVR) response in genotype 1 patients is different according the insulin resistance. The SVR was 60% in patients without insulin resistance versus 20% in patients with strong insulin resistance (HOMA > 4.
The present trial desire to analyze the effect that the treatment of insulin resistance produce in higher range of RVS.
- Conditions
- Chronic Hepatitis C
- Being tested
- Metformine, Placebo of metformine
- Keywords
- insulin resistance, chronic hepatitis C, genotype 1
- Medical subject headings
- Hepatitis C, Chronic, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetformineDrug
850-2550 mg/daily for 48 weeks
Placebo of metformineOther
850-2550 mg/daily for 48 weeks
| Study group | Role | What they receive |
|---|---|---|
| 2 | Placebo comparator | Placebo of metformine 850-2550 mg/daily for 48 weeks Receives: Other: Placebo of metformine |
| 1 | Experimental | Metformine 850-2550 mg/daily for 48 weeks Receives: Drug: Metformine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with HCV-RNA
Measured: Week 72
Secondary outcomes (1)
Percentage of patients who has erradicated the insulin resistance
Measured: week 72
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2007 (estimated)
- Study startMay 2006
- Study completionJan 2007
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valme University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Manuel Romero-Gomez, Dr, Study director, Hospital Universitario de Valme. Sevilla
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00546442
- Sponsor's protocol ID
- 2005-02446-19
- Other IDs
- 2005
- Acronym
- TRIC-1
- Status last verified
- Oct 2007
- First submitted
- 17 Oct 2007
- Last updated
- 19 Oct 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Treatment of Insulin Resistance in Patients With Chronic Hepatitis C Genotype 1 Treated With Peginterferon Alfa-2a in Combination With Ribavirin in Current Clinical Practice
- ClinicalTrials.gov ID
- NCT00546442
- Acronym / sponsor ID
- TRIC-1 / 2005-02446-19
- Conditions
- Chronic Hepatitis C
- Keywords
- insulin resistance, chronic hepatitis C, genotype 1
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Valme University HospitalUniversity, hospital or other
- Study start
- May 2006
- Study completion
- Jan 2007 (actual)
- First posted
- 19 Oct 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.
To evaluate the effect of treatment of insulin resistance in the response of chronic hepatitis C treatment, mesure as HCV-RNA negative at week 72.
4.3.2 Objetivos secundarios To evaluate the efficacy and safety of treatment with metformine to erradicate the insulin resistance of patients with chornic hepatitis C genotype 1 measure as HOMA-IR < 2.
Detailed description
Differents studies show that infection by virus hepatitis C have a relevant rol in the development of insulin resistance. The insulin resistence is associated with a progression of fibrosis and the development of steatosis. The insulin resistence is frecuently associated with very difficult to cure patients as cirrhotics, afro-american patients, overweight patients and co-infected HCV-HIV patients. Recently is repported that sustained virological (SVR) response in genotype 1 patients is different according the insulin resistance. The SVR was 60% in patients without insulin resistance versus 20% in patients with strong insulin resistance (HOMA > 4.
The present trial desire to analyze the effect that the treatment of insulin resistance produce in higher range of RVS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Placebo comparator | Other: Placebo of metforminePlacebo of metformine 850-2550 mg/daily for 48 weeks |
| 1 | Experimental | Drug: MetformineMetformine 850-2550 mg/daily for 48 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male and female patients with 18 years of age or more
- Serum HCV-RNA quantifiable
- Genotype 1
- Liver disease compensated
- HOMA-IR > 2
Key exclusion criteria (21 listed)
- Liver chirrosis
- Diabetes
- Women with ongoing pregnancy or breast feeding
- HIV positive
- Patients who during 6 months previous to treatment loss more of 10% of weight
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 |
|---|---|---|
| Metformine850-2550 mg/daily for 48 weeks | Drug | 1 |
| Placebo of metformine850-2550 mg/daily for 48 weeks | Other | 2 |
Primary outcome
Percentage of patients with HCV-RNA
Time frame: Week 72
1 secondary outcome
Percentage of patients who has erradicated the insulin resistance
Time frame: week 72
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 19 Oct 2007.
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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.
Manuel Romero-Gomez, Dr study director
Hospital Universitario de Valme. Sevilla
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Metformine in people with Chronic Hepatitis C, run by Valme University Hospital at 19 sites in Spain.
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 8 inclusion and 21 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 19 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Spain. 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?
Percentage of patients with HCV-RNA (time frame: Week 72). 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 19 Oct 2007.