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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

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Chronic Hepatitis C Infection
Interventions Drug: ACH-0143102
Drug: Ribavirin
Enrollment 8
Recruitment Details Participants were recruited from 6 sites in the US between September 5, 2012 and December 11, 2012.
Pre-assignment Details Participants were screened within 4 weeks (-28 to -1) before administration of study drug. Subjects who meet all eligibility criteria were instructed to arrive at the study center on baseline day.
Arm/Group Title ACH-0143102 Plus Ribavirin
Hide Arm/Group Description

ACH-0143102 225 mg loading dose on Day 1 followed by 75 mg maintenance dose on Days 2-84. Weight-based RBV (as per the label) for Days 1-84.

ACH-0143102

Ribavirin

Period Title: Overall Study
Started 8
Completed 6
Not Completed 2
Reason Not Completed
Physician Decision             2
Arm/Group Title ACH-0143102 Plus Ribavirin
Hide Arm/Group Description

ACH-0143102 225 mg loading dose on Day 1 followed by 75 mg maintenance dose on Days 2-84. RBV (as per label) for Days 1-84.

ACH-0143102

Ribavirin

Overall Number of Baseline Participants 8
Hide Baseline Analysis Population Description
The analysis population for baseline characteristics was all enrolled subjects.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants
50.07  (11.34)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
<=18 years
0
   0.0%
Between 18 and 65 years
8
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
Female
2
  25.0%
Male
6
  75.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
American Indian or Alaska Native
0
   0.0%
Asian
2
  25.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
6
  75.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 8 participants
28.13  (4.183)
1.Primary Outcome
Title SVR12
Hide Description 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
Time Frame 12 weeks following last dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ACH-0143102 Plus Ribavirin
Hide Arm/Group Description:

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.

ACH-0143102

Ribavirin

Overall Number of Participants Analyzed 8
Measure Type: Number
Unit of Measure: percentage of subjects
50
Time Frame Adverse event data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up, for up to 36 weeks.
Adverse Event Reporting Description Treatment-emergent adverse events are summarized.
 
Arm/Group Title ACH-0143102 Plus Ribavirin
Hide Arm/Group Description

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.

ACH-0143102

Ribavirin

All-Cause Mortality
ACH-0143102 Plus Ribavirin
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
ACH-0143102 Plus Ribavirin
Affected / at Risk (%)
Total   0/8 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
ACH-0143102 Plus Ribavirin
Affected / at Risk (%)
Total   6/8 (75.00%) 
Blood and lymphatic system disorders   
Anaemia  1  4/8 (50.00%) 
Cardiac disorders   
Atrioventricular block second degree  1  1/8 (12.50%) 
Gastrointestinal disorders   
Abdominal pain upper  1  1/8 (12.50%) 
Diarrhoea  1  1/8 (12.50%) 
Eructation  1  1/8 (12.50%) 
Haematochezia  1  1/8 (12.50%) 
Nausea  1  2/8 (25.00%) 
Oral pain  1  1/8 (12.50%) 
General disorders   
Fatigue  1  5/8 (62.50%) 
Influenza like illness  1  1/8 (12.50%) 
Irritability  1  1/8 (12.50%) 
Non-cardiac chest pain  1  1/8 (12.50%) 
Infections and infestations   
Folliculitis  1  1/8 (12.50%) 
Influenza  1  1/8 (12.50%) 
Nasopharyngitis  1  1/8 (12.50%) 
Sinusitis  1  1/8 (12.50%) 
Injury, poisoning and procedural complications   
Foreign body in eye  1  1/8 (12.50%) 
Muscle strain  1  1/8 (12.50%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  1/8 (12.50%) 
Back pain  1  1/8 (12.50%) 
Joint swelling  1  1/8 (12.50%) 
Nervous system disorders   
Dizziness  1  1/8 (12.50%) 
Headache  1  2/8 (25.00%) 
Psychiatric disorders   
Emotional disorder  1  1/8 (12.50%) 
Insomnia  1  2/8 (25.00%) 
Reproductive system and breast disorders   
Breast tenderness  1  1/8 (12.50%) 
Vulvovaginal pruritus  1  1/8 (12.50%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnoea  1  1/8 (12.50%) 
Sinus congestion  1  1/8 (12.50%) 
Upper respiratory tract congestion  1  1/8 (12.50%) 
Skin and subcutaneous tissue disorders   
Dry skin  1  1/8 (12.50%) 
Pruritus  1  3/8 (37.50%) 
Rash  1  2/8 (25.00%) 
Rash macular  1  2/8 (25.00%) 
Rash maculo-papular  1  1/8 (12.50%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Prior to submitting/presenting a manuscript or materials relating to a Study to a publisher, reviewer, or outside person, the Institution shall provide to Achillion a copy of all such manuscripts or materials, and Achillion shall have thirty (30) days to review and comment. The Institution shall, upon Achillion's request, further delay publication or presentation for a period of up to sixty (60) days to allow Achillion to protect its interests in any Achillion Inventions.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Kevin Kucharski, VP of Clinical Operations
Organization: Achillion Pharmaceuticals
Phone: 203-624-7000
EMail: Kkucharski@achillion.com
Layout table for additonal information
Responsible Party: Alexion Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01700179    
Other Study ID Numbers: ACH102-005
First Submitted: October 2, 2012
First Posted: October 4, 2012
Results First Submitted: September 30, 2014
Results First Posted: October 3, 2014
Last Update Posted: October 10, 2014