Trial Outcomes & Findings for A Study to Evaluate the Safety and Antiviral Effect of ABT-450/Ritonavir and ABT-530 Coadministered With and Without Ribavirin in Adults With Genotype 3 Hepatitis C (HCV) Infection (NCT NCT02068222)
NCT ID: NCT02068222
Last Updated: 2018-02-22
Results Overview
SVR12 defined as hepatitis C (HCV) ribonucleic acid (RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
10 participants
Primary outcome timeframe
12 weeks after last dose of study drug
Results posted on
2018-02-22
Participant Flow
Participant milestones
| Measure |
ABT-450/r and ABT-530 Plus RBV
ABT-450/r (150 mg/100 mg) once daily (QD) co-administered with ABT-530 (120 mg) once daily (QD) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
ABT-450/ritonavir (r): Tablet
ABT-530: Tablet
Ribavirin (RBV): Tablet
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
ABT-450/r and ABT-530 Plus RBV
ABT-450/r (150 mg/100 mg) once daily (QD) co-administered with ABT-530 (120 mg) once daily (QD) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
ABT-450/ritonavir (r): Tablet
ABT-530: Tablet
Ribavirin (RBV): Tablet
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
A Study to Evaluate the Safety and Antiviral Effect of ABT-450/Ritonavir and ABT-530 Coadministered With and Without Ribavirin in Adults With Genotype 3 Hepatitis C (HCV) Infection
Baseline characteristics by cohort
| Measure |
ABT-450/r and ABT-530 Plus RBV
n=10 Participants
ABT-450/r (150 mg/100 mg) once daily (QD) co-administered with ABT-530 (120 mg) once daily (QD) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
ABT-450/ritonavir (r): Tablet
ABT-530: Tablet
Ribavirin (RBV): Tablet
|
|---|---|
|
Age, Continuous
|
52.5 years
STANDARD_DEVIATION 10.19 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeks after last dose of study drugSVR12 defined as hepatitis C (HCV) ribonucleic acid (RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug.
Outcome measures
| Measure |
ABT-450/r and ABT-530 Plus RBV
n=10 Participants
ABT-450/r (150 mg/100 mg) once daily (QD) co-administered with ABT-530 (120 mg) once daily (QD) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
ABT-450/ritonavir (r): Tablet
ABT-530: Tablet
Ribavirin (RBV): Tablet
|
|---|---|
|
The Percentage of Subjects Who Achieve 12-week Sustained Virologic Response (SVR12)
|
90 percentage of participants
Interval 55.5 to 99.7
|
SECONDARY outcome
Timeframe: 24 weeks after last dose of study drugSVR24 defined as HCV RNA LLOQ 24 weeks after last dose of study drug.
Outcome measures
| Measure |
ABT-450/r and ABT-530 Plus RBV
n=10 Participants
ABT-450/r (150 mg/100 mg) once daily (QD) co-administered with ABT-530 (120 mg) once daily (QD) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
ABT-450/ritonavir (r): Tablet
ABT-530: Tablet
Ribavirin (RBV): Tablet
|
|---|---|
|
The Percentage of Subjects Who Achieve 24-week Sustained Virologic Response (SVR24)
|
90 percentage of participants
Interval 55.5 to 99.7
|
SECONDARY outcome
Timeframe: Up to Treatment Week 12Percentage of subjects with quantifiable HCV RNA throughout the entire treatment period, confirmed quantifiable HCV RNA after previously having unquantifiable HCV RNA, or a confirmed increase of at least one log10 in HCV RNA during treatment.
Outcome measures
| Measure |
ABT-450/r and ABT-530 Plus RBV
n=10 Participants
ABT-450/r (150 mg/100 mg) once daily (QD) co-administered with ABT-530 (120 mg) once daily (QD) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
ABT-450/ritonavir (r): Tablet
ABT-530: Tablet
Ribavirin (RBV): Tablet
|
|---|---|
|
The Percentage of Subjects With Virologic Failure During Treatment
|
10 percentage of participants
Interval 0.3 to 44.5
|
SECONDARY outcome
Timeframe: Within 12 weeks after the last dose of study drugPercentage of subjects with confirmed quantifiable HCV RNA within 12 weeks of last dose among subjects with unquantifiable hepatitis C virus ribonucleic acid at the end of treatment.
Outcome measures
| Measure |
ABT-450/r and ABT-530 Plus RBV
n=9 Participants
ABT-450/r (150 mg/100 mg) once daily (QD) co-administered with ABT-530 (120 mg) once daily (QD) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
ABT-450/ritonavir (r): Tablet
ABT-530: Tablet
Ribavirin (RBV): Tablet
|
|---|---|
|
The Percentage of Subjects With Post-Treatment Relapse
|
0 percentage of participants
Interval 0.0 to 0.0
|
Adverse Events
ABT-450/r and ABT-530 Plus RBV
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ABT-450/r and ABT-530 Plus RBV
n=10 participants at risk
ABT-450/r (150 mg/100 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
|
|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
10.0%
1/10 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16.5 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained through end of study (up to 41 weeks).
Treatment-emergent adverse events are defined as any adverse event (AE) with an onset date that is after the first dose of study drug and no more than 30 days after the last dose of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Eye disorders
DRY EYE
|
10.0%
1/10 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16.5 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained through end of study (up to 41 weeks).
Treatment-emergent adverse events are defined as any adverse event (AE) with an onset date that is after the first dose of study drug and no more than 30 days after the last dose of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Gastrointestinal disorders
DIARRHOEA
|
10.0%
1/10 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16.5 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained through end of study (up to 41 weeks).
Treatment-emergent adverse events are defined as any adverse event (AE) with an onset date that is after the first dose of study drug and no more than 30 days after the last dose of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Gastrointestinal disorders
FAECES SOFT
|
10.0%
1/10 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16.5 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained through end of study (up to 41 weeks).
Treatment-emergent adverse events are defined as any adverse event (AE) with an onset date that is after the first dose of study drug and no more than 30 days after the last dose of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Gastrointestinal disorders
NAUSEA
|
20.0%
2/10 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16.5 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained through end of study (up to 41 weeks).
Treatment-emergent adverse events are defined as any adverse event (AE) with an onset date that is after the first dose of study drug and no more than 30 days after the last dose of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
General disorders
CHEST DISCOMFORT
|
10.0%
1/10 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16.5 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained through end of study (up to 41 weeks).
Treatment-emergent adverse events are defined as any adverse event (AE) with an onset date that is after the first dose of study drug and no more than 30 days after the last dose of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
General disorders
FATIGUE
|
40.0%
4/10 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16.5 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained through end of study (up to 41 weeks).
Treatment-emergent adverse events are defined as any adverse event (AE) with an onset date that is after the first dose of study drug and no more than 30 days after the last dose of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
General disorders
MALAISE
|
10.0%
1/10 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16.5 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained through end of study (up to 41 weeks).
Treatment-emergent adverse events are defined as any adverse event (AE) with an onset date that is after the first dose of study drug and no more than 30 days after the last dose of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
General disorders
PAIN
|
10.0%
1/10 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16.5 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained through end of study (up to 41 weeks).
Treatment-emergent adverse events are defined as any adverse event (AE) with an onset date that is after the first dose of study drug and no more than 30 days after the last dose of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
General disorders
PYREXIA
|
10.0%
1/10 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16.5 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained through end of study (up to 41 weeks).
Treatment-emergent adverse events are defined as any adverse event (AE) with an onset date that is after the first dose of study drug and no more than 30 days after the last dose of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
General disorders
THIRST
|
10.0%
1/10 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16.5 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained through end of study (up to 41 weeks).
Treatment-emergent adverse events are defined as any adverse event (AE) with an onset date that is after the first dose of study drug and no more than 30 days after the last dose of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
ACARODERMATITIS
|
10.0%
1/10 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16.5 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained through end of study (up to 41 weeks).
Treatment-emergent adverse events are defined as any adverse event (AE) with an onset date that is after the first dose of study drug and no more than 30 days after the last dose of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
ORAL HERPES
|
10.0%
1/10 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16.5 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained through end of study (up to 41 weeks).
Treatment-emergent adverse events are defined as any adverse event (AE) with an onset date that is after the first dose of study drug and no more than 30 days after the last dose of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
RHINITIS
|
10.0%
1/10 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16.5 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained through end of study (up to 41 weeks).
Treatment-emergent adverse events are defined as any adverse event (AE) with an onset date that is after the first dose of study drug and no more than 30 days after the last dose of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Injury, poisoning and procedural complications
LIMB INJURY
|
10.0%
1/10 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16.5 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained through end of study (up to 41 weeks).
Treatment-emergent adverse events are defined as any adverse event (AE) with an onset date that is after the first dose of study drug and no more than 30 days after the last dose of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
10.0%
1/10 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16.5 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained through end of study (up to 41 weeks).
Treatment-emergent adverse events are defined as any adverse event (AE) with an onset date that is after the first dose of study drug and no more than 30 days after the last dose of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Investigations
HAEMOGLOBIN DECREASED
|
10.0%
1/10 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16.5 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained through end of study (up to 41 weeks).
Treatment-emergent adverse events are defined as any adverse event (AE) with an onset date that is after the first dose of study drug and no more than 30 days after the last dose of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Metabolism and nutrition disorders
ABNORMAL LOSS OF WEIGHT
|
10.0%
1/10 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16.5 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained through end of study (up to 41 weeks).
Treatment-emergent adverse events are defined as any adverse event (AE) with an onset date that is after the first dose of study drug and no more than 30 days after the last dose of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
10.0%
1/10 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16.5 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained through end of study (up to 41 weeks).
Treatment-emergent adverse events are defined as any adverse event (AE) with an onset date that is after the first dose of study drug and no more than 30 days after the last dose of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
20.0%
2/10 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16.5 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained through end of study (up to 41 weeks).
Treatment-emergent adverse events are defined as any adverse event (AE) with an onset date that is after the first dose of study drug and no more than 30 days after the last dose of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
10.0%
1/10 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16.5 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained through end of study (up to 41 weeks).
Treatment-emergent adverse events are defined as any adverse event (AE) with an onset date that is after the first dose of study drug and no more than 30 days after the last dose of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Nervous system disorders
BALANCE DISORDER
|
10.0%
1/10 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16.5 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained through end of study (up to 41 weeks).
Treatment-emergent adverse events are defined as any adverse event (AE) with an onset date that is after the first dose of study drug and no more than 30 days after the last dose of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Nervous system disorders
DIZZINESS
|
20.0%
2/10 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16.5 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained through end of study (up to 41 weeks).
Treatment-emergent adverse events are defined as any adverse event (AE) with an onset date that is after the first dose of study drug and no more than 30 days after the last dose of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Nervous system disorders
HEADACHE
|
10.0%
1/10 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16.5 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained through end of study (up to 41 weeks).
Treatment-emergent adverse events are defined as any adverse event (AE) with an onset date that is after the first dose of study drug and no more than 30 days after the last dose of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Nervous system disorders
SYNCOPE
|
10.0%
1/10 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16.5 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained through end of study (up to 41 weeks).
Treatment-emergent adverse events are defined as any adverse event (AE) with an onset date that is after the first dose of study drug and no more than 30 days after the last dose of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Psychiatric disorders
DEPRESSION
|
10.0%
1/10 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16.5 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained through end of study (up to 41 weeks).
Treatment-emergent adverse events are defined as any adverse event (AE) with an onset date that is after the first dose of study drug and no more than 30 days after the last dose of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Psychiatric disorders
INSOMNIA
|
10.0%
1/10 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16.5 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained through end of study (up to 41 weeks).
Treatment-emergent adverse events are defined as any adverse event (AE) with an onset date that is after the first dose of study drug and no more than 30 days after the last dose of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Psychiatric disorders
IRRITABILITY
|
10.0%
1/10 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16.5 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained through end of study (up to 41 weeks).
Treatment-emergent adverse events are defined as any adverse event (AE) with an onset date that is after the first dose of study drug and no more than 30 days after the last dose of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
30.0%
3/10 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16.5 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained through end of study (up to 41 weeks).
Treatment-emergent adverse events are defined as any adverse event (AE) with an onset date that is after the first dose of study drug and no more than 30 days after the last dose of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
10.0%
1/10 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16.5 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained through end of study (up to 41 weeks).
Treatment-emergent adverse events are defined as any adverse event (AE) with an onset date that is after the first dose of study drug and no more than 30 days after the last dose of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
10.0%
1/10 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16.5 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained through end of study (up to 41 weeks).
Treatment-emergent adverse events are defined as any adverse event (AE) with an onset date that is after the first dose of study drug and no more than 30 days after the last dose of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Skin and subcutaneous tissue disorders
RASH
|
20.0%
2/10 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16.5 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained through end of study (up to 41 weeks).
Treatment-emergent adverse events are defined as any adverse event (AE) with an onset date that is after the first dose of study drug and no more than 30 days after the last dose of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
Additional Information
Global Medical Information
AbbVie
Phone: 800-633-9110
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER