NCT01132313

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

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 488 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Hepatitis C, Chronic

Interventions

Type	Name	Description
DRUG	BI 207127	28 weeks, high dose, TID
DRUG	BI 201335	40 weeks, QD
DRUG	BI 207127	4 weeks, low dose TID
DRUG	BI 201335	24 weeks, QD
DRUG	Ribavirin	16 weeks, according to label
DRUG	Ribavirin	28 weeks, according to label
DRUG	Ribavirin	28 weeks, according to label
DRUG	BI 207127	40 weeks, high dose, TID
DRUG	BI 207127	24 weeks, very high dose, BID
DRUG	BI 207127	16 weeks, standard dose, BID
DRUG	BI 201335	24 weeks, QD
DRUG	Ribavirin	48 weeks, according to label
DRUG	Ribavirin	40 weeks, according to label
DRUG	BI 207127	16 weeks, high dose, TID
DRUG	BI 207127	28 weeks, high dose, TID
DRUG	BI 201335	28 weeks, QD
DRUG	BI 201335	16 weeks, QD
DRUG	Ribavirin	24 weeks, according to label
DRUG	BI 201335	24 weeks, QD
DRUG	BI 201335	28 weeks, QD
DRUG	BI 207127	24 weeks, standard dose, BID
DRUG	BI 201335	24 weeks, QD
DRUG	BI 201335	16 weeks, QD
DRUG	BI 207127	16 weeks, high dose, BID
DRUG	BI 201335	24 weeks, QD
DRUG	Ribavirin	16 weeks, according to label
DRUG	Ribavirin	16 weeks, according to label
DRUG	BI 207217	28 weeks, high dose BID
DRUG	BI 201335	16 weeks, QD
DRUG	BI 207127	24 weeks, high dose, TID
DRUG	Ribavirin	48 weeks, according to label
DRUG	BI 207127	4 weeks, high dose, TID
DRUG	BI 201335	28 weeks, QD
DRUG	Ribavirin	24 weeks, according to label
DRUG	Ribavirin	24 weeks, according to label

Timeline

• Start date: 2010-05-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2010-05-28
• Last updated: 2016-02-01
• Results posted: 2016-02-01

Locations

53 sites across 10 countries: United States, Australia, Austria, France, Germany, New Zealand, Portugal, Romania, Spain, Switzerland