Trial Outcomes & Findings for Boceprevir Drug Combination for Hepatitis C Treatment in People With and Without HIV (NCT NCT01443923)

NCT ID: NCT01443923

Last Updated: 2015-07-13

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

4 participants

Primary outcome timeframe

6 months post treatment

Results posted on

2015-07-13

Participant Flow

Participant milestones

Participant milestones
Measure	1-HCV Hepatitis C Mono-infected Boceprevir Peg-Interferon-alfa 2B Ribavirin	2 HCV/HIV Hepatitis C and HIV co-Infected Boceprevir Peg-Interferon-alfa 2B Ribavirin
Overall Study STARTED	3	1
Overall Study COMPLETED	2	1
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	1-HCV Hepatitis C Mono-infected Boceprevir Peg-Interferon-alfa 2B Ribavirin	2 HCV/HIV Hepatitis C and HIV co-Infected Boceprevir Peg-Interferon-alfa 2B Ribavirin
Overall Study Adverse Event	1	0

Baseline Characteristics

Boceprevir Drug Combination for Hepatitis C Treatment in People With and Without HIV

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Total n=4 Participants Total of all reporting groups	1-HCV n=3 Participants Hepatitis C Mono-infected Boceprevir Peg-Interferon-alfa 2B Ribavirin	2 HCV/HIV n=1 Participants Hepatitis C and HIV co-Infected Boceprevir Peg-Interferon-alfa 2B Ribavirin
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=5 Participants	0 Participants n=7 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants	3 Participants n=5 Participants	1 Participants n=7 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=5 Participants	0 Participants n=7 Participants
Age, Continuous	57.5 Years STANDARD_DEVIATION 2.64575 • n=5 Participants	58 Years STANDARD_DEVIATION 3 • n=5 Participants	56 Years STANDARD_DEVIATION 0 • n=7 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=5 Participants	0 Participants n=7 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	2 Participants n=5 Participants	1 Participants n=7 Participants
Region of Enrollment United States	4 participants n=5 Participants	3 participants n=5 Participants	1 participants n=7 Participants

PRIMARY outcome

Timeframe: 6 months post treatment

Population: Due to the change in the standard of care treatment of HCV, it became difficult to recruit patients to receive IFN based therapy with the prospects of IFN free treatment being available sooner. Study was prematurely terminated and no data was collected/analyzed for the Outcome.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 0, Day 7

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: End of Treatment

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months post treatment

Outcome measures

Outcome data not reported

Adverse Events

1-HCV

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

2 HCV/HIV

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	1-HCV n=3 participants at risk Hepatitis C Mono-infected Boceprevir Peg-Interferon-alfa 2B Ribavirin	2 HCV/HIV n=1 participants at risk Hepatitis C and HIV co-Infected Boceprevir Peg-Interferon-alfa 2B Ribavirin
Gastrointestinal disorders Abdomina Pain	33.3% 1/3 • Number of events 1	0.00% 0/1
Metabolism and nutrition disorders Hypoalbuminaemia	33.3% 1/3 • Number of events 1	0.00% 0/1
Nervous system disorders Convulsion	33.3% 1/3 • Number of events 1	0.00% 0/1
Renal and urinary disorders Renal Failure Acute	33.3% 1/3 • Number of events 1	0.00% 0/1
Gastrointestinal disorders Vomiting	33.3% 1/3 • Number of events 1	0.00% 0/1

Other adverse events

Other adverse events
Measure	1-HCV n=3 participants at risk Hepatitis C Mono-infected Boceprevir Peg-Interferon-alfa 2B Ribavirin	2 HCV/HIV n=1 participants at risk Hepatitis C and HIV co-Infected Boceprevir Peg-Interferon-alfa 2B Ribavirin
Cardiac disorders Supraventricular Tachycardia	33.3% 1/3 • Number of events 1	0.00% 0/1
Eye disorders Diplopia	0.00% 0/3	100.0% 1/1 • Number of events 1
Eye disorders Eye Pain	0.00% 0/3	100.0% 1/1 • Number of events 1
Gastrointestinal disorders Nausea	33.3% 1/3 • Number of events 1	0.00% 0/1
Gastrointestinal disorders Vomiting	33.3% 1/3 • Number of events 1	0.00% 0/1
General disorders Fatigue	66.7% 2/3 • Number of events 2	0.00% 0/1
General disorders Injection Site Reaction	33.3% 1/3 • Number of events 1	0.00% 0/1
Infections and infestations Cellulitis	33.3% 1/3 • Number of events 1	0.00% 0/1
Infections and infestations Nasopharyngitis	33.3% 1/3 • Number of events 1	0.00% 0/1
Infections and infestations Pneumonia	33.3% 1/3 • Number of events 1	0.00% 0/1
Investigations Alanine aminotransferase increased	33.3% 1/3 • Number of events 1	0.00% 0/1
Investigations Haemoglobin decreased	33.3% 1/3 • Number of events 4	0.00% 0/1
Investigations Neutrophil count decreased	66.7% 2/3 • Number of events 8	100.0% 1/1 • Number of events 2
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/3	100.0% 1/1 • Number of events 1
Metabolism and nutrition disorders Hypoglycaemia	33.3% 1/3 • Number of events 1	100.0% 1/1 • Number of events 1
Metabolism and nutrition disorders Hypomagnesaemia	33.3% 1/3 • Number of events 1	0.00% 0/1
Musculoskeletal and connective tissue disorders Myalgia	33.3% 1/3 • Number of events 1	0.00% 0/1
Nervous system disorders Convulsion	33.3% 1/3 • Number of events 1	0.00% 0/1
Nervous system disorders Headache	33.3% 1/3 • Number of events 2	0.00% 0/1
Renal and urinary disorders Renal Failure Acute	33.3% 1/3 • Number of events 1	0.00% 0/1

Additional Information

Dr. Shyam Kottilil

NIAID/NIH

Phone: 301-435-0936

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place