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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
488
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
1241.21.0003 Boehringer Ingelheim Investigational Site
La Jolla, California, United States
1241.21.0006 Boehringer Ingelheim Investigational Site
San Diego, California, United States
1241.21.0004 Boehringer Ingelheim Investigational Site
San Francisco, California, United States
1241.21.0011 Boehringer Ingelheim Investigational Site
Palm Harbor, Florida, United States
1241.21.0013 Boehringer Ingelheim Investigational Site
Valparaiso, Indiana, United States
Part 1: Rapid Virological Response (RVR)
Part 1: Rapid virological response (RVR), defined as Hepatitis C Virus Ribonucleic acid (HCV RNA) \<25IU/mL at Week 4 of treatment
Time frame: 4 weeks
Part 2: Sustained Virological Response (SVR)
Part 2: Sustained virological response (SVR), defined as HCV RNA \<25 IU/mL and undetectable at 12 weeks after end of treatment
Time frame: From drug administration until 12 weeks after end of treatment, up to 52 weeks
Part 3 and 4: Sustained Virological Response (SVR)
Part 3 and 4: Sustained virological response (SVR) defined as HCV RNA \<25IU/mL and undetectable at 12 weeks after end of treatment
Time frame: From drug administration until 12 weeks after end of treatment, up to 36 weeks
Part 1: Time to Virological Response
Part 1: Time to virological response, defined as the timepoint of the first measurement of plasma HCV RNA level \<25 IU/mL. The percentage of participants who achieved virological response within each time period are displayed for this outcome measure.
Time frame: From drug administration until end of drug administration, up to 4 weeks
Part 2: Time to Virological Response
Part 2: Time to virological response, defined as the timepoint of the first measurement of plasma HCV RNA level \<25 IU/mL. The percentage of participants who achieved virological response within each time period are displayed for this outcome measure.
Time frame: From drug administration until end of drug administration, up to 40 weeks
Part 1 and 2: Plasma HCV RNA Level Not Detectable at Week 4
Part 1 and 2: Plasma Hepatitis C Virus Ribonucleic acid (HCV RNA) level not detectable at Week 4
Time frame: 4 weeks
Part 2: Sustained Virological Response at 4 and 24 Weeks After End of Treatment
Part 2: Sustained virological response at 4 and 24 weeks after end of treatment
Time frame: 4 weeks and 24 weeks after the end of treatment, up to 64 weeks
Part 3 and 4: Plasma HCV RNA Level <25 IU/mL at Week 4 and 12 of Treatment
Part 3 and 4: Plasma Hepatitis C Virus Ribonucleic acid (HCV RNA) level \<25 IU/mL at week 4 and 12 of treatment
Time frame: Week 4 and 12
Part 3 and 4: Sustained Virological Response (SVR) at 4 Weeks After End of Treatment
Part 3 and 4: Sustained virological response (SVR) at 4 weeks after end of treatment
Time frame: up to 28 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
1241.21.0008 Boehringer Ingelheim Investigational Site
Springfield, Massachusetts, United States
1241.21.0019 Boehringer Ingelheim Investigational Site
Fayetteville, North Carolina, United States
1241.21.0012 Boehringer Ingelheim Investigational Site
Arlington, Texas, United States
1241.21.0005 Boehringer Ingelheim Investigational Site
Austin, Texas, United States
1241.21.0007 Boehringer Ingelheim Investigational Site
Dallas, Texas, United States
...and 43 more locations