drugset / Trial / NCT00081770
Peginterferon Dose Evaluations for Previously Untreated Subjects With Chronic Hepatitis C Infected With Genotype 1 (Study P03471)
RandomizedParallel-groupOpen-labelTreatment
Summary
The objective is to compare the safety and efficacy of the following three treatment regimens in previously untreated adult subjects with chronic hepatitis C infected with Genotype 1: (1) PegIntron 1.5 µg/kg/wk in combination with weight based REBETOL (800-1400 mg/day); (2) PegIntron 1µg/kg/wk in combination with weight based REBETOL (800-1400 mg/day); and (3) PEGASYS 180 µg/wk plus COPEGUS 1000-1200 mg/day.
Timeline
- Start
- 2004-03
- Primary completion
- 2007-11
- Completion
- 2007-11
Outcome
Missed primary endpoint
paper rates of sustained virologic response were similar among the regimens: PMID 19625712 ↗
paper P=0.57 for standard-dose peginterferon alfa-2b vs. peginterferon alfa-2a PMID 19625712 ↗
paper P=0.20 for standard-dose vs. low-dose peginterferon alfa-2b PMID 19625712 ↗
Publications
- Results McHutchison JG, Lawitz EJ, Shiffman ML, Muir AJ, Galler GW, McCone J, Nyberg LM, Lee WM, Ghalib RH, Schiff ER, Galati JS, Bacon BR, Davis MN, Mukhopadhyay P, Koury K, Noviello S, Pedicone LD, Brass CA, Albrecht JK, Sulkowski MS; IDEAL Study Team. Peginterferon alfa-2b or alfa-2a with ribavirin for treatment of hepatitis C infection. N Engl J Med. 2009 Aug 6;361(6):580-93. doi: 10.1056/NEJMoa0808010. Epub 2009 Jul 22.
- Melia MT, Muir AJ, McCone J, Shiffman ML, King JW, Herrine SK, Galler GW, Bloomer JR, Nunes FA, Brown KA, Mullen KD, Ravendhran N, Ghalib RH, Boparai N, Jiang R, Noviello S, Brass CA, Albrecht JK, McHutchison JG, Sulkowski MS; IDEAL Study Team. Racial differences in hepatitis C treatment eligibility. Hepatology. 2011 Jul;54(1):70-8. doi: 10.1002/hep.24358.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Peginterferon alfa-2a | Protein / enzyme biologic | 180 ug | Subcutaneous |
| Subject | Peginterferon alfa-2b | Protein / enzyme biologic | 1 ug/kg | Subcutaneous |
| Subject | Peginterferon alfa-2b | Protein / enzyme biologic | 1.5 ug/kg | Subcutaneous |
| Subject | Ribavirin | Small molecule | 800 mg | Oral |
| Subject | Ribavirin | Small molecule | 1000 mg | Oral |
| Subject | Ribavirin | Small molecule | 1200 mg | Oral |
| Subject | Ribavirin | Small molecule | 1400 mg | Oral |