Conditions: Hepatitis C, Chronic
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 488
Healthy volunteers: no

Brief summary:
The substances BI 201335 and BI 207127 are being developed for the treatment of chronic hepatitis C virus infection. BI 201335 and BI 207127 work by preventing the virus from replicating.

The currently available medications pegylated interferon alfa and ribavirin for hepatitis C ca have considerable adverse events in patients and in many cases are not sufficiently effective. This is particularly the case in treatment of patients infected with genotype 1 of HCV.

A combination therapy of these new substances without pegylated interferon alfa may be associated with fewer adverse events that currently available (pegylated interferon-alfa-based) medication and may also provide a treatment option to the large number of patients with contraindications or intolerance to pegylated interferon alfa.

This clinical trial (1241.21) currently consists of 3 distinct studies: Part 1, Part 2 and Part 3.

Part 1 (SOUND-C1) is a 2 armed study as described in experimental arms 1 and 2 below (actual enrollment: 56 patients; randomized and treated: 32) Part 2 (SOUND-C2) is a 5 armed study as described in experimental arms 3 to 7 below (actual enrollment: 465; randomized and treated: 362) Part 3 (SOUND-C3) includes 3 arms as described in experimental arms 8 to 10 below (83 patients randomized and treated)

Detailed description:

Arms:
arm 1: 4 weeks of high dose TID BI 207127 and QD BI 201335 in combination with RBV, Part 1 arm 2: 4 weeks of low dose three times per day (TID) BI 207127 and once daily (QD) BI 201335 in combination with RBV, Part 1 arm 3: 16 weeks of TID BI 207127 and QD BI 201335 in combination with RBV, Part 2 arm 4: 28 weeks of TID BI 207127 and QD BI 201335 in combination with RBV, Part 2 arm 5: 40 weeks of TID BI 207127 and QD BI 201335 in combination with RBV, Part 2 arm 6: 28 weeks of BID BI 207127 and QD BI 201335 in combination with RBV, Part 2 arm 7: 28 weeks of TID BI 207127 and QD BI 201335 without RBV, Part 2 arm 8: 16 weeks of BID BI 207127 and QD BI 201335 in combination with RBV, Part 3 arm 9: 24 weeks of BID BI 207127 and QD BI 201335 in combination with RBV, Part 3 arm 10: 24 weeks of TID BI 207127 and QD BI 201335 in combination with RBV, Part 3 arm 11: 16 weeks of BID BI 207127 and QD BI 201335 in combination with RBV, Part 4 arm 12: 24 weeks of BID BI 207127 and QD BI 201335 in combination with RBV, Part 4

Interventions: intervention 1: BI 207127 intervention 2: BI 201335 intervention 3: BI 207127 intervention 4: BI 201335 intervention 5: Ribavirin intervention 6: Ribavirin intervention 7: Ribavirin intervention 8: BI 207127 intervention 9: BI 207127 intervention 10: BI 207127 intervention 11: BI 201335 intervention 12: Ribavirin intervention 13: Ribavirin intervention 14: BI 207127 intervention 15: BI 207127 intervention 16: BI 201335 intervention 17: BI 201335 intervention 18: Ribavirin intervention 19: BI 201335 intervention 20: BI 201335 intervention 21: BI 207127 intervention 22: BI 201335 intervention 23: BI 201335 intervention 24: BI 207127 intervention 25: BI 201335 intervention 26: Ribavirin intervention 27: Ribavirin intervention 28: BI 207217 intervention 29: BI 201335 intervention 30: BI 207127 intervention 31: Ribavirin intervention 32: BI 207127 intervention 33: BI 201335 intervention 34: Ribavirin intervention 35: Ribavirin
Intervention descriptions: intervention 1: 28 weeks, high dose, TID intervention 2: 40 weeks, QD intervention 3: 4 weeks, low dose TID intervention 4: 24 weeks, QD intervention 5: 16 weeks, according to label intervention 6: 28 weeks, according to label intervention 7: 28 weeks, according to label intervention 8: 40 weeks, high dose, TID intervention 9: 24 weeks, very high dose, BID intervention 10: 16 weeks, standard dose, BID intervention 11: 24 weeks, QD intervention 12: 48 weeks, according to label intervention 13: 40 weeks, according to label intervention 14: 16 weeks, high dose, TID intervention 15: 28 weeks, high dose, TID intervention 16: 28 weeks, QD intervention 17: 16 weeks, QD intervention 18: 24 weeks, according to label intervention 19: 24 weeks, QD intervention 20: 28 weeks, QD intervention 21: 24 weeks, standard dose, BID intervention 22: 24 weeks, QD intervention 23: 16 weeks, QD intervention 24: 16 weeks, high dose, BID intervention 25: 24 weeks, QD intervention 26: 16 weeks, according to label intervention 27: 16 weeks, according to label intervention 28: 28 weeks, high dose BID intervention 29: 16 weeks, QD intervention 30: 24 weeks, high dose, TID intervention 31: 48 weeks, according to label intervention 32: 4 weeks, high dose, TID intervention 33: 28 weeks, QD intervention 34: 24 weeks, according to label intervention 35: 24 weeks, according to label

Protocol document: