Trial Outcomes & Findings for A Study of Vaniprevir (MK-7009) in Participants With Chronic Hepatitis C Infection After Participation in Other Vaniprevir Studies (MK-7009-028) (NCT NCT00943761)
NCT ID: NCT00943761
Last Updated: 2021-02-08
Results Overview
An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
45 participants
Primary outcome timeframe
up to 72 weeks
Results posted on
2021-02-08
Participant Flow
Participant milestones
| Measure |
Vaniprevir 300 mg b.i.d. + Peg-IFN + RBV
Participants received vaniprevir 300 mg twice daily in combination pegylated interferon (peg-IFN) 180 mcg weekly and ribavirin (RBV) 1000 or 1200 mg administered as a divided dose twice daily.
|
Vaniprevir 600 mg b.i.d. + Peg-IFN + RBV
Participants received vaniprevir 600 mg twice daily in combination peg-IFN 180 mcg weekly and ribavirin 1000 or 1200 mg administered as a divided dose twice daily.
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
24
|
|
Overall Study
COMPLETED
|
17
|
23
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
| Measure |
Vaniprevir 300 mg b.i.d. + Peg-IFN + RBV
Participants received vaniprevir 300 mg twice daily in combination pegylated interferon (peg-IFN) 180 mcg weekly and ribavirin (RBV) 1000 or 1200 mg administered as a divided dose twice daily.
|
Vaniprevir 600 mg b.i.d. + Peg-IFN + RBV
Participants received vaniprevir 600 mg twice daily in combination peg-IFN 180 mcg weekly and ribavirin 1000 or 1200 mg administered as a divided dose twice daily.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
Baseline Characteristics
A Study of Vaniprevir (MK-7009) in Participants With Chronic Hepatitis C Infection After Participation in Other Vaniprevir Studies (MK-7009-028)
Baseline characteristics by cohort
| Measure |
Vaniprevir 300 mg b.i.d. + Peg-IFN + RBV
n=21 Participants
Participants received vaniprevir 300 mg twice daily in combination peg-IFN 180 mcg weekly and RBV 1000 or 1200 mg administered as a divided dose twice daily.
|
Vaniprevir 600 mg b.i.d. + Peg-IFN + RBV
n=24 Participants
Participants received vaniprevir 600 mg twice daily in combination peg-IFN 180 mcg weekly and ribavirin 1000 or 1200 mg administered as a divided dose twice daily.
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.5 Years
STANDARD_DEVIATION 7.4 • n=5 Participants
|
48.1 Years
STANDARD_DEVIATION 8.4 • n=7 Participants
|
50.2 Years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 72 weeksPopulation: All participants as treated population consists of all participants who received at least one dose of study treatment.
An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.
Outcome measures
| Measure |
Vaniprevir 300 mg b.i.d. + Peg-IFN + RBV
n=21 Participants
Participants received vaniprevir 300 mg twice daily in combination peg-IFN 180 mcg weekly and RBV 1000 or 1200 mg administered as a divided dose twice daily.
|
Vaniprevir 600 mg b.i.d. + Peg-IFN + RBV
n=24 Participants
Participants received vaniprevir 600 mg twice daily in combination peg-IFN 180 mcg weekly and ribavirin 1000 or 1200 mg administered as a divided dose twice daily.
|
|---|---|---|
|
Number of Participants Who Experienced an Adverse Event
|
21 Participants
|
23 Participants
|
PRIMARY outcome
Timeframe: up to 72 weeksPopulation: All participants as treated population consists of all participants who received at least one dose of study treatment.
Serious adverse event is defined as any adverse drug or biologic or device experience occurring at any dose resulting in death, was life-threatening, was persistent or caused significant disability/incapacity, required in-patient hospitalization or prolonged hospitalization, was a congenital anomaly or birth defect, was a cancer, or was an overdose.
Outcome measures
| Measure |
Vaniprevir 300 mg b.i.d. + Peg-IFN + RBV
n=21 Participants
Participants received vaniprevir 300 mg twice daily in combination peg-IFN 180 mcg weekly and RBV 1000 or 1200 mg administered as a divided dose twice daily.
|
Vaniprevir 600 mg b.i.d. + Peg-IFN + RBV
n=24 Participants
Participants received vaniprevir 600 mg twice daily in combination peg-IFN 180 mcg weekly and ribavirin 1000 or 1200 mg administered as a divided dose twice daily.
|
|---|---|---|
|
Number of Participants Who Experienced a Serious Adverse Event
|
4 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 48 weeksPopulation: All participants as treated population consists of all participants who received at least one dose of study treatment.
An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.
Outcome measures
| Measure |
Vaniprevir 300 mg b.i.d. + Peg-IFN + RBV
n=21 Participants
Participants received vaniprevir 300 mg twice daily in combination peg-IFN 180 mcg weekly and RBV 1000 or 1200 mg administered as a divided dose twice daily.
|
Vaniprevir 600 mg b.i.d. + Peg-IFN + RBV
n=24 Participants
Participants received vaniprevir 600 mg twice daily in combination peg-IFN 180 mcg weekly and ribavirin 1000 or 1200 mg administered as a divided dose twice daily.
|
|---|---|---|
|
Number of Participants Who Discontinued Study Treatment Due to an Adverse Event
|
2 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 72 weeksPopulation: Population includes only a subset of participants previously treated with placebo + peg-IFN + RBV in a vaniprevir study and excludes participants for failure to receive \>=1 dose of study drug, lack of any post-allocation endpoint data subsequent to \>=1 dose of study drug, lack of baseline data, or missing data due to discontinuation from the study
SVR24 is defined as undetectable hepatitis C virus ribonucleic acid (HCV RNA) 24 weeks after the end of vaniprevir study therapy. HCV RNA plasma levels were assessed using the Roche COBAS Taqman assay (or equivalent) with the limit of quantification (LoQ) of at least 25 IU/mL and the limit of detection (LoD) of at least 10 IU/mL.
Outcome measures
| Measure |
Vaniprevir 300 mg b.i.d. + Peg-IFN + RBV
n=18 Participants
Participants received vaniprevir 300 mg twice daily in combination peg-IFN 180 mcg weekly and RBV 1000 or 1200 mg administered as a divided dose twice daily.
|
Vaniprevir 600 mg b.i.d. + Peg-IFN + RBV
n=17 Participants
Participants received vaniprevir 600 mg twice daily in combination peg-IFN 180 mcg weekly and ribavirin 1000 or 1200 mg administered as a divided dose twice daily.
|
|---|---|---|
|
Percentage of Participants Who Achieved Sustained Viral Response 24 Weeks After the End of Treatment (SVR24)
|
66.7 Percentage of participants
Interval 41.0 to 86.7
|
70.6 Percentage of participants
Interval 44.0 to 89.7
|
Adverse Events
Vaniprevir 300 mg Bid + Peg-IFN + RBV
Serious events: 4 serious events
Other events: 21 other events
Deaths: 0 deaths
Vaniprevir 600 mg Bid + Peg-IFN + RBV
Serious events: 1 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vaniprevir 300 mg Bid + Peg-IFN + RBV
n=21 participants at risk
Participants received vaniprevir 300 mg twice daily in combination peg-IFN 180 mcg weekly and RBV 1000 or 1200 mg administered as a divided dose twice daily.
|
Vaniprevir 600 mg Bid + Peg-IFN + RBV
n=24 participants at risk
Participants received vaniprevir 600 mg twice daily in combination peg-IFN 180 mcg weekly and RBV 1000 or 1200 mg administered as a divided dose twice daily.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
4.8%
1/21 • Number of events 1 • up to 72 weeks
|
0.00%
0/24 • up to 72 weeks
|
|
Gastrointestinal disorders
Constipation
|
4.8%
1/21 • Number of events 1 • up to 72 weeks
|
0.00%
0/24 • up to 72 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
4.8%
1/21 • Number of events 1 • up to 72 weeks
|
0.00%
0/24 • up to 72 weeks
|
|
Investigations
Alanine aminotransferase increased
|
4.8%
1/21 • Number of events 1 • up to 72 weeks
|
0.00%
0/24 • up to 72 weeks
|
|
Investigations
Aspartate aminotransferase increased
|
4.8%
1/21 • Number of events 1 • up to 72 weeks
|
0.00%
0/24 • up to 72 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/21 • up to 72 weeks
|
4.2%
1/24 • Number of events 1 • up to 72 weeks
|
Other adverse events
| Measure |
Vaniprevir 300 mg Bid + Peg-IFN + RBV
n=21 participants at risk
Participants received vaniprevir 300 mg twice daily in combination peg-IFN 180 mcg weekly and RBV 1000 or 1200 mg administered as a divided dose twice daily.
|
Vaniprevir 600 mg Bid + Peg-IFN + RBV
n=24 participants at risk
Participants received vaniprevir 600 mg twice daily in combination peg-IFN 180 mcg weekly and RBV 1000 or 1200 mg administered as a divided dose twice daily.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
23.8%
5/21 • Number of events 5 • up to 72 weeks
|
0.00%
0/24 • up to 72 weeks
|
|
Blood and lymphatic system disorders
Neutropenia
|
9.5%
2/21 • Number of events 3 • up to 72 weeks
|
8.3%
2/24 • Number of events 3 • up to 72 weeks
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/21 • up to 72 weeks
|
8.3%
2/24 • Number of events 2 • up to 72 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
9.5%
2/21 • Number of events 2 • up to 72 weeks
|
12.5%
3/24 • Number of events 3 • up to 72 weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
9.5%
2/21 • Number of events 2 • up to 72 weeks
|
8.3%
2/24 • Number of events 2 • up to 72 weeks
|
|
Gastrointestinal disorders
Constipation
|
9.5%
2/21 • Number of events 3 • up to 72 weeks
|
12.5%
3/24 • Number of events 3 • up to 72 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
23.8%
5/21 • Number of events 5 • up to 72 weeks
|
37.5%
9/24 • Number of events 14 • up to 72 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
4.8%
1/21 • Number of events 1 • up to 72 weeks
|
8.3%
2/24 • Number of events 2 • up to 72 weeks
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/21 • up to 72 weeks
|
8.3%
2/24 • Number of events 2 • up to 72 weeks
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/21 • up to 72 weeks
|
12.5%
3/24 • Number of events 3 • up to 72 weeks
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/21 • up to 72 weeks
|
12.5%
3/24 • Number of events 3 • up to 72 weeks
|
|
Gastrointestinal disorders
Mouth ulceration
|
4.8%
1/21 • Number of events 1 • up to 72 weeks
|
12.5%
3/24 • Number of events 3 • up to 72 weeks
|
|
Gastrointestinal disorders
Nausea
|
38.1%
8/21 • Number of events 8 • up to 72 weeks
|
58.3%
14/24 • Number of events 17 • up to 72 weeks
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
3/21 • Number of events 4 • up to 72 weeks
|
8.3%
2/24 • Number of events 4 • up to 72 weeks
|
|
General disorders
Asthenia
|
19.0%
4/21 • Number of events 4 • up to 72 weeks
|
25.0%
6/24 • Number of events 6 • up to 72 weeks
|
|
General disorders
Fatigue
|
33.3%
7/21 • Number of events 7 • up to 72 weeks
|
20.8%
5/24 • Number of events 5 • up to 72 weeks
|
|
General disorders
Influenza like illness
|
14.3%
3/21 • Number of events 4 • up to 72 weeks
|
16.7%
4/24 • Number of events 4 • up to 72 weeks
|
|
General disorders
Irritability
|
9.5%
2/21 • Number of events 2 • up to 72 weeks
|
12.5%
3/24 • Number of events 3 • up to 72 weeks
|
|
General disorders
Pyrexia
|
23.8%
5/21 • Number of events 6 • up to 72 weeks
|
12.5%
3/24 • Number of events 3 • up to 72 weeks
|
|
Infections and infestations
Nasopharyngitis
|
9.5%
2/21 • Number of events 2 • up to 72 weeks
|
12.5%
3/24 • Number of events 4 • up to 72 weeks
|
|
Infections and infestations
Urinary tract infection
|
14.3%
3/21 • Number of events 4 • up to 72 weeks
|
0.00%
0/24 • up to 72 weeks
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/21 • up to 72 weeks
|
8.3%
2/24 • Number of events 7 • up to 72 weeks
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/21 • up to 72 weeks
|
8.3%
2/24 • Number of events 3 • up to 72 weeks
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/21 • up to 72 weeks
|
8.3%
2/24 • Number of events 3 • up to 72 weeks
|
|
Investigations
Weight decreased
|
9.5%
2/21 • Number of events 2 • up to 72 weeks
|
0.00%
0/24 • up to 72 weeks
|
|
Metabolism and nutrition disorders
Decreased appetite
|
9.5%
2/21 • Number of events 3 • up to 72 weeks
|
20.8%
5/24 • Number of events 5 • up to 72 weeks
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
9.5%
2/21 • Number of events 2 • up to 72 weeks
|
0.00%
0/24 • up to 72 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
19.0%
4/21 • Number of events 5 • up to 72 weeks
|
8.3%
2/24 • Number of events 3 • up to 72 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.8%
1/21 • Number of events 1 • up to 72 weeks
|
16.7%
4/24 • Number of events 5 • up to 72 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
14.3%
3/21 • Number of events 3 • up to 72 weeks
|
4.2%
1/24 • Number of events 1 • up to 72 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
14.3%
3/21 • Number of events 3 • up to 72 weeks
|
12.5%
3/24 • Number of events 3 • up to 72 weeks
|
|
Nervous system disorders
Dizziness
|
9.5%
2/21 • Number of events 4 • up to 72 weeks
|
12.5%
3/24 • Number of events 4 • up to 72 weeks
|
|
Nervous system disorders
Headache
|
33.3%
7/21 • Number of events 7 • up to 72 weeks
|
37.5%
9/24 • Number of events 17 • up to 72 weeks
|
|
Nervous system disorders
Sciatica
|
9.5%
2/21 • Number of events 2 • up to 72 weeks
|
0.00%
0/24 • up to 72 weeks
|
|
Nervous system disorders
Tremor
|
9.5%
2/21 • Number of events 2 • up to 72 weeks
|
0.00%
0/24 • up to 72 weeks
|
|
Psychiatric disorders
Insomnia
|
14.3%
3/21 • Number of events 3 • up to 72 weeks
|
20.8%
5/24 • Number of events 5 • up to 72 weeks
|
|
Psychiatric disorders
Sleep disorder
|
14.3%
3/21 • Number of events 4 • up to 72 weeks
|
20.8%
5/24 • Number of events 5 • up to 72 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.5%
2/21 • Number of events 2 • up to 72 weeks
|
29.2%
7/24 • Number of events 7 • up to 72 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.8%
1/21 • Number of events 1 • up to 72 weeks
|
8.3%
2/24 • Number of events 2 • up to 72 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
9.5%
2/21 • Number of events 2 • up to 72 weeks
|
12.5%
3/24 • Number of events 3 • up to 72 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/21 • up to 72 weeks
|
8.3%
2/24 • Number of events 2 • up to 72 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
4.8%
1/21 • Number of events 1 • up to 72 weeks
|
8.3%
2/24 • Number of events 2 • up to 72 weeks
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/21 • up to 72 weeks
|
8.3%
2/24 • Number of events 2 • up to 72 weeks
|
|
Skin and subcutaneous tissue disorders
Eczema
|
9.5%
2/21 • Number of events 2 • up to 72 weeks
|
12.5%
3/24 • Number of events 3 • up to 72 weeks
|
|
Skin and subcutaneous tissue disorders
Erythema
|
4.8%
1/21 • Number of events 1 • up to 72 weeks
|
12.5%
3/24 • Number of events 3 • up to 72 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
23.8%
5/21 • Number of events 5 • up to 72 weeks
|
25.0%
6/24 • Number of events 10 • up to 72 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.3%
3/21 • Number of events 3 • up to 72 weeks
|
4.2%
1/24 • Number of events 1 • up to 72 weeks
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission.
- Publication restrictions are in place
Restriction type: OTHER