Chronic Hepatitis C MedDRA version: 8.1 Level: LLT Classification code 10008912 Term: Chronic hepatitis C
Conditions
Interventions
Product Code: SCH 503034
Pharmaceutical Form: Capsule*
Current Sponsor code: SCH 503034
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Trade Name: PegIntron
Sponsors
Schering-Plough Research Institute
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject must be between 18 and 60 years of age; 2. Subject’s body weight must be between 45 and 125 kg; 3. Subject must have documented chronic hepatitis C genotype 1 with most recent (within 6 months of Day 1) quantitative HCV-RNA result greater than or equal to 10,000 IU/mL; 4. Subject must have a liver biopsy within 5 years of Day 1 with histology consistent with chronic hepatitis and no other etiology for chronic liver disease. A copy of the local pathology report must be available in the site’s file; 5. Subject and subject's partner(s) must each agree to use acceptable methods of contraception 2 weeks prior to Day 1 and at least 6 months or longer if dictated by local regulations after last dose of study drug (see Section 7.6.1). In section 7.6.1 the study protocol defines that females must be using one of the following methods of birth control: a. diaphragm, b. tubal ligation, c. intrauterine device (IUD), d. sponge and spermicide, e. appropriate contraception registered for marketing containing an estrogen and/ or progesterone agent (oral, transdermal, intramuscular, or implant). As the use of a diaphragm, a non-hormonal intrauterine device (IUD) or a sponge and spermicide as birth control method is not safe enough according to the Note for guidance on non-clinical safety studies for the conduct of human clinical trials for pharmaceuticals (CPMP/ICH/286/95), the following change in section 7.6.1. of the study protocol will apply: Sexual-active females of childbearing potential who use a diaphragm, a non-hormonal intrauterine-device (IUD) or a sponge and spermicide will not be included into the study. 6. Subjects must be willing to give written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Subjects who received prior treatment for hepatitis C 2. Subjects known to be co-infected with HIV or hepatitis B virus (HBsAg positive) 3. Evidence of decompensated liver disease as specified in the protocol 4. Diabetic and hypersensitive subjects with clinically significant ocular exam findings: retinopathy, cotton wool spots, optic nerve disorder, retinal hemorrhage, or any other clinically significant abnormality 5. Pre-existing psychiatric condition as specified in the protocol 6. Clinical diagnosis of substance abuse of the following drugs within the following timeframes (not including time spent in detoxification, hospitalization, or incarceration) a. Alcohol, intravenous drugs, inhalational (not including marijuana), psychotropics, narcotics, cocaine use, prescription or over-the-counter drugs: within 1 year of the screening visit b. Multi-drug abuse (2 or more substances in 6a): within 3 years of screening visit OR Subjects receiving opiate agonist substitution therapy within 1 year of Screening visit OR Subject’s historic marijuana use is deemed excessive by the Principal Investigator (or physician listed on FDA Form 1572) or is interfering with the subject's life, then the subject is not eligible. If subject's marijuana use is not deemed excessive and does not interfere with life, subject must be instructed to discontinue any current use of recreational marijuana prior to entry into study and throughout the study period. 7. Any known pre-existing medical condition that could interfere with the subject’s participation in and completion of the study as specified in the protocol. 8. Evidence of active or suspected malignancy, or a history of malignancy, within the last 5 years (except adequately treated basal cell carcinoma of the skin) 9. Subjects who are pregnant or nursing. Subjects who intend to become pregnant during the study period. Male subjects with partners who are, or intend to become, pregnant during the study period 10. Any other condition which, in the opinion of the Principal Investigator, or physician listed in FDA Form 1572 would make the subject unsuitable for enrollment or could interfere with the subject participating in and completing the study. 11. Participation in any other clinical trial within 30 days of the screening visit or intention to participate in another clinical trial during participation in this study. Collection of additional blood, urine, or tissue samples or additional data, beyond that specified in this protocol, is prohibited (other than that related to subject’s medical care). 12. Treatment with any investigation drug within 30 days of screening visit in this study. 13. Subjects who are part of the site personnel directly involved with this study. 14. Subjects who are family members of the investigational study staff. Laboratory Exclusion Criteria NOTE: If any of the laboratory exclusion criteria are met, then the site may have the subject retested. If a single value is more than 10% outside the listed laboratory exclusion criterion value, the clinical significance of this value may be discussed with the sponsor’s Project Physician for enrollment consideration. 15. Hematologic, biochemical, and serologic criteria (growth factors may not be used to achieve study entry requirements: a. Hemoglobin 1.5 x ULN (upper limit of normal) of the laboratory refe
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the efficacy of SCH 503034 800 mg TID PO in combination with PegIntron 1.5 µg/kg QW SC plus ribavirin (800-1400 mg QD PO) in previously untreated adult CHC subjects infected with Genotype 1.;Secondary Objective: 1. To evaluate the safety of SCH 503034 when used in combination with PegIntron 1.5 µg/kg QW SC plus ribavirin (800-1400 mg QD PO). 2. To assess the relationship of a) early virologic response (EVR) and b) time to HCV-RNA negative, to sustained virologic response (SVR). 3. To assess the effect of the 4 week lead in with PegIntron and ribavirin on SVR (FW 24). 4.To assess the effect of duration of treatment with SCH 503034 on SVR. 5. To assess the proportion of subjects with HCV-RNA levels below the limit of detection at FW 12. 6. To assess the proportion of subjects with HCV-RNA levels below the limit of detection at 72 weeks post randomization. 7. To explore the relationship between virologic response at FW 12, FW 24 (SVR), and 72 weeks post randomization. ;Primary end point(s): The primary efficacy endpoint is the achievement of SVR, defined as plasma HCV-RNA level below the lower limit of detection at follow-up week 24 (FW 24). Subjects will be declared treatment failures in one of the following ways: • Subjects in any of the 5 treatment arms who are HCV-RNA positive at FW 24. • Subjects in any of the 5 treatment arms who are missing their HCV-RNA level at FW 24 and are not HCV-RNA negative at FW 12. | — |
Countries
Belgium, France, Germany, Italy, Netherlands, Portugal
Outcome results
None listed