At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Safety, Antiviral Effect and Pharmacokinetics of BI 207127 in Combination With BI 201335 and With or Without Ribavirin for 4, 16, 24, 28 or 40 Weeks in Patients With Chronic HCV Genotype 1 Infection (Randomized Phase Ib/II)
In Brief
A Phase 2 clinical trial evaluating BI 207127, BI 201335, and 2 other interventions for Hepatitis C, Chronic. Completed, enrolled 488 participants across 53 sites in 10 countries.
Detailed 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)
Study Details
Timeline
Interventions
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