TMC435350-TiDP16-C202: A Study to Assess the Activity of TMC435 on Hepatitis C Virus in Patients Who Have Never Received Treatment for Their Hepatitis C Infection.

This study has been completed.
Sponsor:
Information provided by:
Tibotec Pharmaceuticals, Ireland
ClinicalTrials.gov Identifier:
NCT00812331
First received: December 18, 2008
Last updated: March 28, 2013
Last verified: March 2013
  Purpose

The primary objective of this study is to assess the activity of TMC435 on hepatitis C virus genotype 2, 3, 4, 5 and 6 replication when administered for 7 days to patients who have never been treated for their hepatitis C infection. This is an exploratory study. Viral kinetics, safety and pharmacokinetic / pharmacodynamic relationship will be studied.


Condition Intervention Phase
Hepatitis C, Chronic
Hepatitis C
Infection
Drug: TMC435
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label Trial in Genotype 2, 3, 4, 5 and 6 Hepatitis C-infected Subjects to Evaluate the Antiviral Activity, Safety, Tolerability and Pharmacokinetics of TMC435350 Following 7 Days Once Daily Dosing as Monotherapy.

Resource links provided by NLM:


Further study details as provided by Tibotec Pharmaceuticals, Ireland:

Primary Outcome Measures:
  • Determine the antiviral effect of TMC435 during 7 days once daily dosing at 200mg orally (by mouth) as monotherapy in treatment naïve, genotype 2 to 6 HCV-infected patients.

Secondary Outcome Measures:
  • Determine the safety, tolerability and PK profile of TMC435 during 7 days once daily dosing at 200mg as monotherapy in treatment naïve, genotype 2 to 6 HCV-infected patients.

Enrollment: 37
Study Start Date: February 2009
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Detailed Description:

This is an open-label, phase IIa study to assess the activity of TMC435 in patients who have never been treated for their hepatitis C infection. The study consists of a screening period of maximum 6 weeks, a treatment period of 7 days and a follow-up period of 4 weeks. A total of 40 HCV-infected patients who have never been treated for HCV (8 patients per HCV genotype) will be enrolled in the study. All patients will receive TMC435 200mg once daily orally (by mouth) for 7 days. Subsequently, they can continue with Standard of Care (SoC) treatment consisting of pegylated interferon and ribavirin upon agreement with the study doctor. The SoC will be given outside the scope of this study. The primary objective in the study is to determine the antiviral activity of TMC435 when administered as monotherapy to treatment naïve, genotype 2 to 6 HCV-infected patients at a daily dose of 200mg orally (by mouth) for 7 days. During the treatment period, all patients will be assessed on a daily basis until 4 days following the last intake of TMC435. HCV viral load quantification and safety / tolerability assessments will be performed. Virologic and pharmacokinetic (PK) assessments for pharmacokinetic / pharmacodynamic analyses will be performed during the investigational treatment period. TMC435 200 mg once daily orally (by mouth) for 7 days as monotherapy

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Documented chronic genotype 2, 3, 4, 5 or 6 hepatitis C infection
  • HCV treatment-naïve patients
  • amount of virus in the blood (HCV RNA) >= 100.000 IU/ml

Exclusion Criteria:

  • Evidence of Child Pugh B or C liver disease, decompensated liver disease or any other form of non-viral hepatitis
  • patients co-infected with HIV type 1 or 2, or Hepatitis A or B, or active tuberculosis
  • patients (male or women of childbearing potential) not agreeing to use highly effective birth control methods from screening through 90 days after the last dose of TMC435 and to continue if applicable (i.e. when continuing on SoC treatment)
  • clinical conditions that would compromise the patient's safety / outcome in the trial
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00812331

Sponsors and Collaborators
Tibotec Pharmaceuticals, Ireland
Investigators
Study Director: Tibotec Pharmaceuticals Clinical Trial Tibotec Pharmaceutical Limited
  More Information

No publications provided

Responsible Party: Compound Development Team Leader, Tibotec Pharmaceuticals Limited
ClinicalTrials.gov Identifier: NCT00812331     History of Changes
Other Study ID Numbers: CR012604
Study First Received: December 18, 2008
Last Updated: March 28, 2013
Health Authority: Ireland: Irish Agriculture and Food Development Authority

Keywords provided by Tibotec Pharmaceuticals, Ireland:
TMC435350-TiDP16-C202
TMC435350-C202
TMC435
Hepatitis
Hepatitis C
Tibotec

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic

ClinicalTrials.gov processed this record on July 24, 2014