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Completed

NCT Number: 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

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)

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Key information

Conditions

Hepatitis C, Chronic Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

1241.21.61002 Boehringer Ingelheim Investigational Site, Heidelberg, Victoria, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Chronic hepatitis C virus (HCV) infection of genotype (GT) 1
  • Parts 1-3:Treatment naive to Interferon -alfa (IFN), Pegylated interferon -alfa (PegIFN), ribavirin (RBV), and any direct acting antiviral agent for chronic hepatitis C
  • Part 4: Treatment experienced with confirmed prior virological failure to an approved dose of PegIFN/RBV (null-response)
  • HCV RNA >=10,000 IU/mL at screening
  • Liver biopsy within two years or fibroscan within six months prior to baseline
  • Liver biopsy within two years or fibroscan within 6 months prior to screening
  • Age 18-75 years

Exclusion criteria

  • Hepatitis C virus (HCV) infection of mixed genotype
  • Evidence of liver disease due to causes other than chronic HCV infection
  • Positive ELISA for human immunodeficiency virus (HIV)
  • Hepatitis B virus (HBV) infection
  • Decompensated liver disease or history of decompensated liver disease
  • Active or suspected malignancy within the last 5 years
  • Ongoing or historical photosensitivity or recurrent rash
  • History of alcohol or drug abuse (except cannabis) within the past 12 months
  • Body mass index (BMI)I <18 or > 35 kg/m2
  • Usage of any investigational drugs within 30 days prior to enrolment, or 5 half-lives, whichever is longer; o the planned usage of an investigational drug during the course of the current study
  • Known hypersensitivity to any ingredient of the study drugs
  • A condition that is defined as one which in the opinion of the investigator may interfere with the patient's capability for participation in the trial or may influence the results of the trial
  • Alpha fetoprotein >100ng/mL at screening; if >20ng/mL and <=100ng/mL, patients can be included if there is no evidence of liver cancer in an appropriate imaging study within 6 months prior to randomisation
  • Total bilirubin > 2 mg/dL with ratio of direct/indirect > 1
  • AST or ALT >5xULN
  • INR prolonged to >1.7xULN
  • Requirement for chronic systemic corticosteroids
  • Received concomitant systemic antiviral, hematopoietic growth factor, or immunomodulatory treatment within 30 days prior to enrolment or 5 half-lives, whichever is longer
  • Received silymarin or glycyrrhizin or Sho-saiko-to within 30 days prior to enrolment
  • Contraindications pertaining to PegIFN or RBV

Treatment and study plan

BI 207127

Drug

28 weeks, high dose, TID

BI 201335

Drug

40 weeks, QD

Ribavirin

Drug

16 weeks, according to label

BI 207217

Drug

28 weeks, high dose BID

Primary outcomes

  1. Part 1: Rapid Virological Response (RVR)

    Time frame: 4 weeks

    Part 1: Rapid virological response (RVR), defined as Hepatitis C Virus Ribonucleic acid (HCV RNA) <25IU/mL at Week 4 of treatment

  2. Part 2: Sustained Virological Response (SVR)

    Time frame: From drug administration until 12 weeks after end of treatment, up to 52 weeks

    Part 2: Sustained virological response (SVR), defined as HCV RNA <25 IU/mL and undetectable at 12 weeks after end of treatment

  3. Part 3 and 4: Sustained Virological Response (SVR)

    Time frame: From drug administration until 12 weeks after end of treatment, up to 36 weeks

    Part 3 and 4: Sustained virological response (SVR) defined as HCV RNA <25IU/mL and undetectable at 12 weeks after end of treatment

Secondary outcomes

  1. Part 1: Time to Virological Response

    Time frame: From drug administration until end of drug administration, up to 4 weeks

    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.

  2. Part 2: Time to Virological Response

    Time frame: From drug administration until end of drug administration, up to 40 weeks

    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.

  3. Part 1 and 2: Plasma HCV RNA Level Not Detectable at Week 4

    Time frame: 4 weeks

    Part 1 and 2: Plasma Hepatitis C Virus Ribonucleic acid (HCV RNA) level not detectable at Week 4

  4. 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 2: Sustained virological response at 4 and 24 weeks after end of treatment

  5. Part 3 and 4: Plasma HCV RNA Level <25 IU/mL at Week 4 and 12 of Treatment

    Time frame: Week 4 and 12

    Part 3 and 4: Plasma Hepatitis C Virus Ribonucleic acid (HCV RNA) level <25 IU/mL at week 4 and 12 of treatment

  6. Part 3 and 4: Sustained Virological Response (SVR) at 4 Weeks After End of Treatment

    Time frame: up to 28 weeks

    Part 3 and 4: Sustained virological response (SVR) at 4 weeks after end of treatment

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

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)

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
May 28, 2010
Registry last updated
Feb 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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