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TMC435350-TiDP16-C202: A Study to Assess the Activity of TMC435 on Hepatitis C Virus in Patients Who Have Been Infected With the Hepatitis C Virus for a Long Time and Have Never Received Treatment for Their Hepatitis C Infection.
This study is not yet open for participant recruitment.
Verified by Tibotec Pharmaceuticals Limited, Ireland, December 2008
Sponsored by: Tibotec Pharmaceuticals Limited, Ireland
Information provided by: Tibotec Pharmaceuticals Limited, Ireland
ClinicalTrials.gov Identifier: NCT00812331
  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 been infected with the hepatitis C virus for a long time and 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 II

MedlinePlus related topics: Hepatitis Hepatitis C
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
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.

Further study details as provided by Tibotec Pharmaceuticals Limited, 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 naÃ-ve, 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 naÃ-ve, genotype 2 to 6 HCV-infected patients.

Estimated Enrollment: 40
Estimated Primary Completion Date: June 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 been infected with the hepatitis C virus (HCV) for a long time and who have never been treated for their hepatits 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 mounth) 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 outcome in the study is to determine the antiviral effect 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00812331

Contacts
Contact: This study is not yet recruiting patients. Please check back for future recruiting sites, or email info1@veritasmedicine.com

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

Responsible Party: Tibotec Pharmaceuticals Limited ( Compound Development Team Leader )
Study ID Numbers: CR012604
Study First Received: December 18, 2008
Last Updated: December 23, 2008
ClinicalTrials.gov Identifier: NCT00812331  
Health Authority: Ireland: Irish Agriculture and Food Development Authority

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

Study placed in the following topic categories:
Virus Diseases
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Chronic
Hepatitis, Viral, Human
Hepatitis C
Hepatitis C, Chronic

Additional relevant MeSH terms:
Communicable Diseases
RNA Virus Infections
Flaviviridae Infections
Infection

ClinicalTrials.gov processed this record on January 13, 2009