Safety, Antiviral Effect and PK of BI 207127 + BI 201335 +/- RBV for 4 up to 40 Weeks in Patients With Chronic HCV Genotype 1 Infection
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis C; Hepatitis C, Chronic
Study type: Interventional
Phase: Phase 2

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)
    


Intervention name(s): BI 207127; BI 201335; BI 207127; BI 201335; Ribavirin; Ribavirin; Ribavirin; BI 207127; BI 207127; BI 207127; BI 201335; Ribavirin; Ribavirin; BI 207127; BI 207127; BI 201335; BI 201335; Ribavirin; BI 201335; BI 201335; BI 207127; BI 201335; BI 201335; BI 207127; BI 201335; Ribavirin; Ribavirin; BI 207217; BI 201335; BI 207127; Ribavirin; BI 207127; BI 201335; Ribavirin; Ribavirin
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 28 weeks, high dose, TID; 40 weeks, QD; 4 weeks, low dose TID; 24 weeks, QD; 16 weeks, according to label; 28 weeks, according to label; 28 weeks, according to label; 40 weeks, high dose, TID; 24 weeks, very high dose, BID; 16 weeks, standard dose, BID; 24 weeks, QD; 48 weeks, according to label; 40 weeks, according to label; 16 weeks, high dose, TID; 28 weeks, high dose, TID; 28 weeks, QD; 16 weeks, QD; 24 weeks, according to label; 24 weeks, QD; 28 weeks, QD; 24 weeks, standard dose, BID; 24 weeks, QD; 16 weeks, QD; 16 weeks, high dose, BID; 24 weeks, QD; 16 weeks, according to label; 16 weeks, according to label; 28 weeks, high dose BID; 16 weeks, QD; 24 weeks, high dose, TID; 48 weeks, according to label; 4 weeks, high dose, TID; 28 weeks, QD; 24 weeks, according to label; 24 weeks, according to label
Intervention MeSH terms: Ribavirin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment