Trial Outcomes & Findings for A Pilot Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of ABT-450 With Ritonavir (ABT-450/r) Dosed in Combination With ABT-072 and Ribavirin (RBV) (NCT NCT01221298)

NCT ID: NCT01221298

Last Updated: 2015-01-08

Results Overview

Analysis of the percentage of participants with hepatitis C virus ribonucleic acid less than the lower limit of quantitation (\< 25 IU/mL).

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 11 participants
• Primary outcome timeframe: Week 4 through Week 12
• Results posted on: 2015-01-08

Participant Flow

Participant milestones

Measure	ABT-450/r and ABT-072, Plus Ribavirin (RBV) ABT-450/r (150/100 mg) once daily (QD) and ABT-072 (400 mg) QD plus weight-based RBV divided twice daily (BID) for 12 weeks.
Overall Study STARTED	11
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Pilot Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of ABT-450 With Ritonavir (ABT-450/r) Dosed in Combination With ABT-072 and Ribavirin (RBV)

Baseline characteristics by cohort

Measure	ABT-450/r and ABT-072, Plus Ribavirin (RBV) n=11 Participants ABT-450/r (150/100 mg) once daily (QD) and ABT-072 (400 mg) QD plus weight-based RBV divided twice daily (BID) for 12 weeks.
Age, Continuous	56.4 years STANDARD_DEVIATION 7.35 • n=93 Participants
Sex: Female, Male Female	3 Participants n=93 Participants
Sex: Female, Male Male	8 Participants n=93 Participants
Hepatitis C Virus (HCV) Genotype/ Subtype 1A	8 participants n=93 Participants
Hepatitis C Virus (HCV) Genotype/ Subtype 1B	3 participants n=93 Participants
Interleukin 28B (IL28B) Genotype CC	11 participants n=93 Participants
Interleukin 28B (IL28B) Genotype CT	0 participants n=93 Participants
Interleukin 28B (IL28B) Genotype TT	0 participants n=93 Participants
Interleukin 28B (IL28B) Genotype Missing	0 participants n=93 Participants

PRIMARY outcome

Timeframe: Week 4 through Week 12

Population: For the percentage of subjects with HCV RNA suppressed below the LLOQ from Week 4 through Week 12 out of all subjects dosed, it was assumed that if 60% of subjects were successfully suppressed from Week 4 through Week 12 then 20 subjects would give a 95% two-sided confidence interval of (36.1%, 80.9%) using binomial exact methods.

Analysis of the percentage of participants with hepatitis C virus ribonucleic acid less than the lower limit of quantitation (< 25 IU/mL).

Outcome measures

Measure	ABT-450/r and ABT-072, Plus Ribavirin (RBV) n=11 Participants ABT-450/r (150/100 mg) once daily (QD) and ABT-072 (400 mg) QD plus weight-based RBV divided twice daily (BID) for 12 weeks.
Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Suppressed Below the Lower Limit of Quantitation (LLOQ) From Week 4 Through Week 12	100 percentage of participants

SECONDARY outcome

Timeframe: Week 2

Population: Efficacy analyses included all participants who received at least 1 dose of study drug (ITT). Participants with missing data were imputed as failures.

Analysis of participants with HCV RNA levels below 1000 IU/mL at Week 2.

Outcome measures

Measure	ABT-450/r and ABT-072, Plus Ribavirin (RBV) n=11 Participants ABT-450/r (150/100 mg) once daily (QD) and ABT-072 (400 mg) QD plus weight-based RBV divided twice daily (BID) for 12 weeks.
Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) < 1000 International Units Per Milliliter (IU/mL)	100 percentage of participants

SECONDARY outcome

Timeframe: Week 4

Population: Efficacy analyses included all participants who received at least 1 dose of study drug (ITT). Participants with missing data were imputed as failures.

Analysis of percentage of participants with hepatitis C virus ribonucleic acid less than the lower limit of quantitation (< 25 IU/mL).

Outcome measures

Measure	ABT-450/r and ABT-072, Plus Ribavirin (RBV) n=11 Participants ABT-450/r (150/100 mg) once daily (QD) and ABT-072 (400 mg) QD plus weight-based RBV divided twice daily (BID) for 12 weeks.
Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Below the Lower Limit of Quantitation (LLOQ) at Week 4	100 percentage of participants

SECONDARY outcome

Timeframe: Post-treatment Day 1 to Post-treatment Week 12

Population: Efficacy analyses included all participants who received at least 1 dose of study drug (ITT). Participants with missing data were imputed as failures.

Sustained Virologic Response 12 (SVR12) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (< LLOQ; < 25 IU/mL) 12 weeks after the last dose of study drug.

Outcome measures

Measure	ABT-450/r and ABT-072, Plus Ribavirin (RBV) n=11 Participants ABT-450/r (150/100 mg) once daily (QD) and ABT-072 (400 mg) QD plus weight-based RBV divided twice daily (BID) for 12 weeks.
Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment	90.9 percentage of participants

SECONDARY outcome

Timeframe: Post-treatment Day 1 to Post-treatment Week 24

Population: Efficacy analyses included all participants who received at least 1 dose of study drug (ITT). Participants with missing data were imputed as failures.

Sustained Virologic Response 24 (SVR24) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ; < 25 IU/mL) 24 weeks after the last dose of study drug.

Outcome measures

Measure	ABT-450/r and ABT-072, Plus Ribavirin (RBV) n=11 Participants ABT-450/r (150/100 mg) once daily (QD) and ABT-072 (400 mg) QD plus weight-based RBV divided twice daily (BID) for 12 weeks.
Percentage of Participants With Sustained Virologic Response 24 Weeks (SVR24) Post-Treatment	90.9 percentage of participants

SECONDARY outcome

Timeframe: Day 1 through Week 12

Population: Efficacy analyses included all participants who received at least 1 dose of study drug (ITT).

The time to failure to suppress was defined as first day a participant met any virologic stopping criteria during treatment. The virologic stopping criteria also includes failure to achieve a 2 log10 IU/mL decrease in HCV RNA by Week 1, failure to achieve HCV RNA <LLOQ by Week 6, or rebound, defined as first day of 2 consecutive increases of at least 0.5 log10 IU/mL above nadir (local minimum value) or confirmed HCV RNA > lower limit of detection (LLOD) for participants who previously achieved HCV RNA < LLOD.

Outcome measures

Measure	ABT-450/r and ABT-072, Plus Ribavirin (RBV) n=11 Participants ABT-450/r (150/100 mg) once daily (QD) and ABT-072 (400 mg) QD plus weight-based RBV divided twice daily (BID) for 12 weeks.
Time to Failure to Suppress or Rebound During Treatment	NA Days Standard Error NA The time to failure to suppress or rebound during treatment could not be estimated, as no participant met failure to suppress or rebound criteria.

SECONDARY outcome

Timeframe: Post-treatment Day 1 to Post-treatment Week 24

Population: Efficacy analyses included all participants who received at least 1 dose of study drug (ITT) with hepatitis C virus (HCV) ribonucleic acid (RNA) \< lower limit of quantitation (LLOQ) at the final treatment visit who completed treatment.

Time to confirmed hepatitis C virus (HCV) ribonucleic acid (RNA) ≥ lower limit of quantitation (LLOQ) (2 consecutive measurements ≥ LLOQ) at any point in the post-treatment period among participants with HCV RNA < LLOQ at the end of treatment.

Outcome measures

Measure	ABT-450/r and ABT-072, Plus Ribavirin (RBV) n=11 Participants ABT-450/r (150/100 mg) once daily (QD) and ABT-072 (400 mg) QD plus weight-based RBV divided twice daily (BID) for 12 weeks.
Time to Virologic Relapse Through 24 Weeks Post-treatment	84 Days 95% Confidence Interval NA Cannot be estimated as only one participant relapsed.

Adverse Events

ABT-450/r and ABT-072, Plus Ribavirin (RBV)

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	ABT-450/r and ABT-072, Plus Ribavirin (RBV) n=11 participants at risk ABT-450/r (150/100 mg) once daily (QD) and ABT-072 (400 mg) QD plus weight-based RBV divided twice daily (BID) for 12 weeks.
Ear and labyrinth disorders VERTIGO	9.1% 1/11 • Adverse Events were collected from the time of study drug administration to 30 days after last dose of study drug (up to 16 weeks). Serious Adverse Events were also collected from the time that informed consent was obtained until 30 days after last dose (64 weeks).
Eye disorders VISUAL ACUITY REDUCED	9.1% 1/11 • Adverse Events were collected from the time of study drug administration to 30 days after last dose of study drug (up to 16 weeks). Serious Adverse Events were also collected from the time that informed consent was obtained until 30 days after last dose (64 weeks).
Gastrointestinal disorders ABDOMINAL DISCOMFORT	9.1% 1/11 • Adverse Events were collected from the time of study drug administration to 30 days after last dose of study drug (up to 16 weeks). Serious Adverse Events were also collected from the time that informed consent was obtained until 30 days after last dose (64 weeks).
Gastrointestinal disorders ABDOMINAL PAIN	9.1% 1/11 • Adverse Events were collected from the time of study drug administration to 30 days after last dose of study drug (up to 16 weeks). Serious Adverse Events were also collected from the time that informed consent was obtained until 30 days after last dose (64 weeks).
Gastrointestinal disorders ABDOMINAL PAIN UPPER	9.1% 1/11 • Adverse Events were collected from the time of study drug administration to 30 days after last dose of study drug (up to 16 weeks). Serious Adverse Events were also collected from the time that informed consent was obtained until 30 days after last dose (64 weeks).
Gastrointestinal disorders DIARRHOEA	9.1% 1/11 • Adverse Events were collected from the time of study drug administration to 30 days after last dose of study drug (up to 16 weeks). Serious Adverse Events were also collected from the time that informed consent was obtained until 30 days after last dose (64 weeks).
Gastrointestinal disorders DYSPEPSIA	9.1% 1/11 • Adverse Events were collected from the time of study drug administration to 30 days after last dose of study drug (up to 16 weeks). Serious Adverse Events were also collected from the time that informed consent was obtained until 30 days after last dose (64 weeks).
Gastrointestinal disorders FOOD POISONING	9.1% 1/11 • Adverse Events were collected from the time of study drug administration to 30 days after last dose of study drug (up to 16 weeks). Serious Adverse Events were also collected from the time that informed consent was obtained until 30 days after last dose (64 weeks).
Gastrointestinal disorders GASTROOESOPHAGEAL REFLUX DISEASE	18.2% 2/11 • Adverse Events were collected from the time of study drug administration to 30 days after last dose of study drug (up to 16 weeks). Serious Adverse Events were also collected from the time that informed consent was obtained until 30 days after last dose (64 weeks).
Gastrointestinal disorders NAUSEA	27.3% 3/11 • Adverse Events were collected from the time of study drug administration to 30 days after last dose of study drug (up to 16 weeks). Serious Adverse Events were also collected from the time that informed consent was obtained until 30 days after last dose (64 weeks).
Gastrointestinal disorders VOMITING	9.1% 1/11 • Adverse Events were collected from the time of study drug administration to 30 days after last dose of study drug (up to 16 weeks). Serious Adverse Events were also collected from the time that informed consent was obtained until 30 days after last dose (64 weeks).
General disorders FATIGUE	27.3% 3/11 • Adverse Events were collected from the time of study drug administration to 30 days after last dose of study drug (up to 16 weeks). Serious Adverse Events were also collected from the time that informed consent was obtained until 30 days after last dose (64 weeks).
General disorders INFLUENZA LIKE ILLNESS	9.1% 1/11 • Adverse Events were collected from the time of study drug administration to 30 days after last dose of study drug (up to 16 weeks). Serious Adverse Events were also collected from the time that informed consent was obtained until 30 days after last dose (64 weeks).
Infections and infestations OTITIS MEDIA	9.1% 1/11 • Adverse Events were collected from the time of study drug administration to 30 days after last dose of study drug (up to 16 weeks). Serious Adverse Events were also collected from the time that informed consent was obtained until 30 days after last dose (64 weeks).
Injury, poisoning and procedural complications POST-TRAUMATIC PAIN	9.1% 1/11 • Adverse Events were collected from the time of study drug administration to 30 days after last dose of study drug (up to 16 weeks). Serious Adverse Events were also collected from the time that informed consent was obtained until 30 days after last dose (64 weeks).
Metabolism and nutrition disorders DIABETES MELLITUS	9.1% 1/11 • Adverse Events were collected from the time of study drug administration to 30 days after last dose of study drug (up to 16 weeks). Serious Adverse Events were also collected from the time that informed consent was obtained until 30 days after last dose (64 weeks).
Metabolism and nutrition disorders GOUT	9.1% 1/11 • Adverse Events were collected from the time of study drug administration to 30 days after last dose of study drug (up to 16 weeks). Serious Adverse Events were also collected from the time that informed consent was obtained until 30 days after last dose (64 weeks).
Nervous system disorders DIZZINESS	9.1% 1/11 • Adverse Events were collected from the time of study drug administration to 30 days after last dose of study drug (up to 16 weeks). Serious Adverse Events were also collected from the time that informed consent was obtained until 30 days after last dose (64 weeks).
Nervous system disorders DYSGEUSIA	9.1% 1/11 • Adverse Events were collected from the time of study drug administration to 30 days after last dose of study drug (up to 16 weeks). Serious Adverse Events were also collected from the time that informed consent was obtained until 30 days after last dose (64 weeks).
Nervous system disorders HEADACHE	36.4% 4/11 • Adverse Events were collected from the time of study drug administration to 30 days after last dose of study drug (up to 16 weeks). Serious Adverse Events were also collected from the time that informed consent was obtained until 30 days after last dose (64 weeks).
Nervous system disorders TENSION HEADACHE	9.1% 1/11 • Adverse Events were collected from the time of study drug administration to 30 days after last dose of study drug (up to 16 weeks). Serious Adverse Events were also collected from the time that informed consent was obtained until 30 days after last dose (64 weeks).
Psychiatric disorders ANXIETY	9.1% 1/11 • Adverse Events were collected from the time of study drug administration to 30 days after last dose of study drug (up to 16 weeks). Serious Adverse Events were also collected from the time that informed consent was obtained until 30 days after last dose (64 weeks).
Psychiatric disorders INSOMNIA	9.1% 1/11 • Adverse Events were collected from the time of study drug administration to 30 days after last dose of study drug (up to 16 weeks). Serious Adverse Events were also collected from the time that informed consent was obtained until 30 days after last dose (64 weeks).
Respiratory, thoracic and mediastinal disorders DYSPNOEA	9.1% 1/11 • Adverse Events were collected from the time of study drug administration to 30 days after last dose of study drug (up to 16 weeks). Serious Adverse Events were also collected from the time that informed consent was obtained until 30 days after last dose (64 weeks).
Respiratory, thoracic and mediastinal disorders NASAL CONGESTION	9.1% 1/11 • Adverse Events were collected from the time of study drug administration to 30 days after last dose of study drug (up to 16 weeks). Serious Adverse Events were also collected from the time that informed consent was obtained until 30 days after last dose (64 weeks).
Skin and subcutaneous tissue disorders DRY SKIN	27.3% 3/11 • Adverse Events were collected from the time of study drug administration to 30 days after last dose of study drug (up to 16 weeks). Serious Adverse Events were also collected from the time that informed consent was obtained until 30 days after last dose (64 weeks).
Skin and subcutaneous tissue disorders ECZEMA	9.1% 1/11 • Adverse Events were collected from the time of study drug administration to 30 days after last dose of study drug (up to 16 weeks). Serious Adverse Events were also collected from the time that informed consent was obtained until 30 days after last dose (64 weeks).
Skin and subcutaneous tissue disorders PRURITUS GENERALISED	9.1% 1/11 • Adverse Events were collected from the time of study drug administration to 30 days after last dose of study drug (up to 16 weeks). Serious Adverse Events were also collected from the time that informed consent was obtained until 30 days after last dose (64 weeks).
Skin and subcutaneous tissue disorders RASH	18.2% 2/11 • Adverse Events were collected from the time of study drug administration to 30 days after last dose of study drug (up to 16 weeks). Serious Adverse Events were also collected from the time that informed consent was obtained until 30 days after last dose (64 weeks).

Additional Information

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