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Evaluation of Safety Tolerability and Antiviral Activity of ACH-0143102 Plus RBV Treatment Naive HCV GT1b Subjects

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ClinicalTrials.gov Identifier: NCT01700179
Recruitment Status : Completed
First Posted : October 4, 2012
Results First Posted : October 3, 2014
Last Update Posted : October 10, 2014
Sponsor:
Information provided by (Responsible Party):
Alexion Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE October 2, 2012
First Posted Date  ICMJE October 4, 2012
Results First Submitted Date  ICMJE September 30, 2014
Results First Posted Date  ICMJE October 3, 2014
Last Update Posted Date October 10, 2014
Study Start Date  ICMJE September 2012
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 2, 2012)
SVR12 [ Time Frame: 12 weeks following last dose ]
To determine the incidence of a sustained virologic response at 12 weeks after the completion of dosing (SVR12) with ACH-0143102 plus ribavirin, reported as HCV RNA less than the limit of quantification (<LOQ) at that time point
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: October 2, 2012)
  • Safety and tolerability [ Time Frame: 12 weeks ]
    Adverse events, ECG, Vital Signs, Physical Exams and clinical laboratory evaluations.
  • To determine complete early virologic response(cEVR) [ Time Frame: 12 weeks ]
    To determine the incidence of a complete early virologic response (cEVR), defined as HCV RNA reported as undetectable at Week 12, for combination therapy of ACH-0143102 plus RBV for 12 weeks in subjects with HVC infection genotype 1b.
  • To determine the incidence of a rapid virologic response(RVR) [ Time Frame: 12 weeks ]
    To determine the incidence of a rapid virologic response (RVR), defined as HCV RNA<limit of quantification(LOQ) at Week 4, for combination therapy of ACH-0143102 plus RBV in subjects with HCV infection genotype 1b.
  • To determine the incidence of an extended rapid virologic response(eRVR) [ Time Frame: 12 weeks ]
    To determine the incidence of an extended rapid virologic response(eRVR), defined as HCV RNA reported as undetectable at Weeks 4 and 12, for subjects treated with combination therapy of ACH-0143102 plus RBV in subjects infected with hepatitis C virus genotype 1b.
  • To determine the incidence of a sustained virologic response [ Time Frame: 24 weeks ]
    To determine the incidence of a sustained virologic response at 4,8, and 24 weeks after the completion of dosing(SVR4,SVR12,and SVR24) with ACH-0143102 plus ribavirin, reported as HCV RNA less than the limit of quantification(<LOQ) at those time points.
  • To determine the pharmacokinetic and pharmacodynamic relationship of ACH-0143102 and RBV treatment and virologic response [ Time Frame: 24 weeks ]
    AUC,Cmax,Tmax,virologic response.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Safety Tolerability and Antiviral Activity of ACH-0143102 Plus RBV Treatment Naive HCV GT1b Subjects
Official Title  ICMJE A Phase 1b, Open-label, Pilot Study to Evaluate the Safety, Tolerability and Antiviral Activity of Oral ACH-0143102 Administered in Combination With Ribavirin for 12 Weeks in Treatment Naive Subjects With Chronic Hepatitis C Virus Infection Genotype 1b.
Brief Summary The purpose of this study is to evaluate the safety, tolerability and efficacy of 12 weeks of treatment with ACH-0143102 and ribavirin in GT1b, treatment-naive, HCV subjects.
Detailed Description A phase 1b, pilot study to evaluate the safety, tolerability and antiviral activity of oral ACH-0143102 administered in combination with ribavirin for 12 weeks in treatment naive subjects with chronic hepatitis C virus infection genotype 1b.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Hepatitis C Infection
Intervention  ICMJE
  • Drug: ACH-0143102
  • Drug: Ribavirin
Study Arms  ICMJE Experimental: ACH-0143102 plus ribavirin daily
ACH-0143102 225 mg loading dose on Day 1 followed by 75 mg maintenance dose on Days 2-84. Weight-based RBV(as per label) for Days 1-84.
Interventions:
  • Drug: ACH-0143102
  • Drug: Ribavirin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 10, 2014)
8
Original Estimated Enrollment  ICMJE
 (submitted: October 2, 2012)
16
Actual Study Completion Date  ICMJE September 2013
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Males and females 18 years and older
  • Clinical diagnosis of hepatitis C with genotype 1b
  • Chronic hepatitis C treatment naive subjects
  • IL28B genotype CC
  • HCV RNA > 10000 IU/mL at screening
  • Females must be willing to use two effective methods of contraception during dosing period and for six months after the last dose of ribavirin.
  • Male patients must be willing to use an effective barrier method of contraception throughout the dosing period and for six months after the last dose of ribavirin. Males must agree to not donate sperm while enrolled in the study and for six months after the last dose of ribavirin.
  • Willing to participate in all study activities and all study requirements.

Exclusion Criteria:

  • BMI>36
  • Pregnant or nursing females
  • Clinically significant laboratory abnormalities at screening
  • Previous participation in a clinical trial with protease inhibitor and/or NS5A inhibitor
  • HIV infection or other liver diseases
  • Positive Hepatitis B Surface Antigen
  • Liver cirrhosis
  • Uncontrolled psychiatric disease
  • Clinical evidence of chronic cardiac disease
  • History of malignancy of any organ system within 5 years
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01700179
Other Study ID Numbers  ICMJE ACH102-005
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alexion Pharmaceuticals
Study Sponsor  ICMJE Alexion Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Alexion Pharmaceuticals
Verification Date October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP