Trial Outcomes & Findings for Evaluation of Safety, Tolerability, and Antiviral Activity of ACH-0143102 Plus Ribavirin In Treatment-naive Hepatitis C Virus Infection Genotype 1b Participants (NCT NCT01700179)

Last Updated: 2023-08-29

Results Overview

To determine the incidence of the SVR12 after the completion of dosing with ACH-0143102 plus ribavirin, reported as hepatitis C virus ribonucleic acid less than the limit of quantification at that time point.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

8 participants

Primary outcome timeframe

12 weeks following the last dose

Results posted on

2023-08-29

Participant Flow

Participants were recruited from 6 sites in the United States between 05 September 2012 and 11 December, 2012.

Participants were screened within 4 weeks (-28 to -1 days) before administration of the study drug. Participants who meet all eligibility criteria were instructed to arrive at the study center on the baseline day.

Participant milestones

Participant milestones
Measure	ACH-0143102 Plus Ribavirin ACH-0143102 (225 milligrams \[mg\]) loading dose on Day 1, followed by maintenance doses (75 mg) on Days 2-84, plus weight-based ribavirin as per label on Days 1-84.
Overall Study STARTED	8
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	ACH-0143102 Plus Ribavirin ACH-0143102 (225 milligrams \[mg\]) loading dose on Day 1, followed by maintenance doses (75 mg) on Days 2-84, plus weight-based ribavirin as per label on Days 1-84.
Overall Study Physician Decision	2

Baseline Characteristics

Evaluation of Safety, Tolerability, and Antiviral Activity of ACH-0143102 Plus Ribavirin In Treatment-naive Hepatitis C Virus Infection Genotype 1b Participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ACH-0143102 Plus Ribavirin n=8 Participants ACH-0143102 (225 mg) loading dose on Day 1, followed by maintenance doses (75 mg) on Days 2-84, plus weight-based ribavirin as per label on Days 1-84.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	50.07 years STANDARD_DEVIATION 11.34 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Body Mass Index	28.13 kilograms/meter squared STANDARD_DEVIATION 4.183 • n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks following the last dose

Outcome measures

Outcome measures
Measure	ACH-0143102 Plus Ribavirin n=8 Participants ACH-0143102 (225 mg) loading dose on Day 1, followed by maintenance doses (75 mg) on Days 2-84, plus weight-based ribavirin as per label on Days 1-84.
Sustained Virologic Response At 12 Weeks (SVR12)	50 percentage of participants

Adverse Events

ACH-0143102 Plus Ribavirin

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	ACH-0143102 Plus Ribavirin n=8 participants at risk ACH-0143102 (225 mg) loading dose on Day 1, followed by maintenance doses (75 mg) on Days 2-84, plus weight-based ribavirin as per label on Days 1-84.
Blood and lymphatic system disorders Anaemia	50.0% 4/8 • 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. Treatment-emergent adverse events are summarized.
Cardiac disorders Atrioventricular block second degree	12.5% 1/8 • 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. Treatment-emergent adverse events are summarized.
Gastrointestinal disorders Abdominal pain upper	12.5% 1/8 • 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. Treatment-emergent adverse events are summarized.
Gastrointestinal disorders Diarrhoea	12.5% 1/8 • 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. Treatment-emergent adverse events are summarized.
Gastrointestinal disorders Eructation	12.5% 1/8 • 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. Treatment-emergent adverse events are summarized.
Gastrointestinal disorders Haematochezia	12.5% 1/8 • 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. Treatment-emergent adverse events are summarized.
Gastrointestinal disorders Nausea	25.0% 2/8 • 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. Treatment-emergent adverse events are summarized.
Gastrointestinal disorders Oral pain	12.5% 1/8 • 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. Treatment-emergent adverse events are summarized.
General disorders Fatigue	62.5% 5/8 • 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. Treatment-emergent adverse events are summarized.
General disorders Influenza like illness	12.5% 1/8 • 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. Treatment-emergent adverse events are summarized.
General disorders Irritability	12.5% 1/8 • 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. Treatment-emergent adverse events are summarized.
General disorders Non-cardiac chest pain	12.5% 1/8 • 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. Treatment-emergent adverse events are summarized.
Infections and infestations Folliculitis	12.5% 1/8 • 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. Treatment-emergent adverse events are summarized.
Infections and infestations Influenza	12.5% 1/8 • 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. Treatment-emergent adverse events are summarized.
Infections and infestations Nasopharyngitis	12.5% 1/8 • 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. Treatment-emergent adverse events are summarized.
Infections and infestations Sinusitis	12.5% 1/8 • 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. Treatment-emergent adverse events are summarized.
Injury, poisoning and procedural complications Foreign body in eye	12.5% 1/8 • 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. Treatment-emergent adverse events are summarized.
Injury, poisoning and procedural complications Muscle strain	12.5% 1/8 • 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. Treatment-emergent adverse events are summarized.
Musculoskeletal and connective tissue disorders Arthralgia	12.5% 1/8 • 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. Treatment-emergent adverse events are summarized.
Musculoskeletal and connective tissue disorders Back pain	12.5% 1/8 • 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. Treatment-emergent adverse events are summarized.
Musculoskeletal and connective tissue disorders Joint swelling	12.5% 1/8 • 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. Treatment-emergent adverse events are summarized.
Nervous system disorders Dizziness	12.5% 1/8 • 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. Treatment-emergent adverse events are summarized.
Nervous system disorders Headache	25.0% 2/8 • 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. Treatment-emergent adverse events are summarized.
Psychiatric disorders Emotional disorder	12.5% 1/8 • 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. Treatment-emergent adverse events are summarized.
Psychiatric disorders Insomnia	25.0% 2/8 • 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. Treatment-emergent adverse events are summarized.
Reproductive system and breast disorders Breast tenderness	12.5% 1/8 • 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. Treatment-emergent adverse events are summarized.
Reproductive system and breast disorders Vulvovaginal pruritus	50.0% 1/2 • 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. Treatment-emergent adverse events are summarized.
Respiratory, thoracic and mediastinal disorders Dyspnoea	12.5% 1/8 • 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. Treatment-emergent adverse events are summarized.
Respiratory, thoracic and mediastinal disorders Sinus congestion	12.5% 1/8 • 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. Treatment-emergent adverse events are summarized.
Respiratory, thoracic and mediastinal disorders Upper respiratory tract congestion	12.5% 1/8 • 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. Treatment-emergent adverse events are summarized.
Skin and subcutaneous tissue disorders Dry skin	12.5% 1/8 • 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. Treatment-emergent adverse events are summarized.
Skin and subcutaneous tissue disorders Pruritus	37.5% 3/8 • 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. Treatment-emergent adverse events are summarized.
Skin and subcutaneous tissue disorders Rash	25.0% 2/8 • 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. Treatment-emergent adverse events are summarized.
Skin and subcutaneous tissue disorders Rash macular	25.0% 2/8 • 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. Treatment-emergent adverse events are summarized.
Skin and subcutaneous tissue disorders Rash maculo-papular	12.5% 1/8 • 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. Treatment-emergent adverse events are summarized.

Additional Information

Alexion Pharmaceuticals Inc.

Phone: 855-752-2356

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Prior to submitting/presenting a manuscript or materials relating to a Study to a publisher, reviewer, or outside person, the Institution shall provide to Sponsor a copy of all such manuscripts or materials, and Sponsor shall have thirty (30) days to review and comment. The Institution shall, upon Sponsor's request, further delay publication or presentation for a period of up to sixty (60) days to allow Sponsor to protect its interests in any Sponsor Inventions.
Publication restrictions are in place

Restriction type: OTHER