Effect of Insulin Resistance on the Safety and Efficacy of Pegylated Interferon and Ribavirin Treatment in HCV (Study P05562)
NCT ID: NCT00705224
Last Updated: 2015-07-01
Study Results
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View full resultsBasic Information
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COMPLETED
250 participants
OBSERVATIONAL
2008-05-31
2010-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients with chronic hepatitis C
Naïve patients with chronic hepatitis C (CHC) of any genotype will be treated with a standard treatment regimen (pegylated interferon and ribavirin) according to routine clinical practice in Russia.
Pegylated Interferon
Routine treatment with a combination of any pegylated interferon and ribavirin was used according to the label/local practice in Russia.
The treatment course duration complied with the labeled dosage regimen. Each dose of pegylated interferon was administered as a subcutaneous
injection calculated as 1.5 mcg/kg once a week. Therapy duration varied from 24 to 48 weeks depending on Hepatitis C virus (HCV) genotype, viral load, activity and stage of hepatitis C.
The Sponsor did not provide formal drug supply.
Ribavirin
Routine treatment with a combination of any pegylated interferon and ribavirin was used according to the label/local practice in Russia.
The treatment course duration complied with the labeled dosage regimen. Ribavirin was taken orally as 200 mg gelatinous capsules. The daily dose varied from 800 to 1200 mg (depending on patient's body weight) twice daily in the
morning and in the evening with meal. Therapy duration varied from 24 to 48 weeks depending on HCV genotype, viral load, activity and stage of hepatitis C.
The Sponsor did not provide formal drug supply.
Interventions
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Pegylated Interferon
Routine treatment with a combination of any pegylated interferon and ribavirin was used according to the label/local practice in Russia.
The treatment course duration complied with the labeled dosage regimen. Each dose of pegylated interferon was administered as a subcutaneous
injection calculated as 1.5 mcg/kg once a week. Therapy duration varied from 24 to 48 weeks depending on Hepatitis C virus (HCV) genotype, viral load, activity and stage of hepatitis C.
The Sponsor did not provide formal drug supply.
Ribavirin
Routine treatment with a combination of any pegylated interferon and ribavirin was used according to the label/local practice in Russia.
The treatment course duration complied with the labeled dosage regimen. Ribavirin was taken orally as 200 mg gelatinous capsules. The daily dose varied from 800 to 1200 mg (depending on patient's body weight) twice daily in the
morning and in the evening with meal. Therapy duration varied from 24 to 48 weeks depending on HCV genotype, viral load, activity and stage of hepatitis C.
The Sponsor did not provide formal drug supply.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Naïve Pegylated Interferon (PEG-IFN) CHC patient
* No contraindications for PEG-IFN CHC therapy
* Negative urine pregnancy test result (for females of childbearing potential) documented within the 24-hour period prior to the first dose of study drugs. Additionally, all female patients of childbearing potential and all males with female partners of childbearing potential must use two forms of effective contraception (combined) during treatment and 6 months after treatment end
* Willingness to give written informed consent and willingness to participate in and comply with the study requirements.
Exclusion Criteria
* Contraindications for PEG-IFN CHC therapy
* Females who are pregnant or breast-feeding
* Male partners of females who are pregnant
* Potentially unreliable participants, and those judged by the investigator to be unsuitable for the study.
18 Years
65 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Other Identifiers
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P05562
Identifier Type: -
Identifier Source: org_study_id
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