Trial Outcomes & Findings for Grazoprevir (MK-5172) With Peg-Interferon and Ribavirin in Participants With Chronic Genotype 2 or 3 Hepatitis C (MK-5172-012) (NCT NCT01440595)

Last Updated: 2024-05-22

Results Overview

cEVR was defined as undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12. HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v.2.0 assay.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

5 participants

Primary outcome timeframe

Week 12

Results posted on

2024-05-22

Participant Flow

No participants were randomized to the Grazoprevir 800 mg + Peg-IFN + RBV arm.

Participant milestones

Participant milestones
Measure	Grazoprevir 200 mg + Peg-IFN + RBV Grazoprevir 200 mg once daily by mouth in combination with Peg-IFN and RBV for 12 weeks.	Grazoprevir 400 mg + Peg-IFN + RBV Grazoprevir 400 mg once daily by mouth in combination with Peg-IFN and RBV for 12 weeks.	Placebo + Peg-IFN + RBV Placebo to grazoprevir once daily by mouth in combination with Peg-IFN and RBV for 12 weeks, followed by open-label Peg-IFN and RBV for an additional 12 weeks.
Overall Study STARTED	1	3	1
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	1	3	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Grazoprevir 200 mg + Peg-IFN + RBV Grazoprevir 200 mg once daily by mouth in combination with Peg-IFN and RBV for 12 weeks.	Grazoprevir 400 mg + Peg-IFN + RBV Grazoprevir 400 mg once daily by mouth in combination with Peg-IFN and RBV for 12 weeks.	Placebo + Peg-IFN + RBV Placebo to grazoprevir once daily by mouth in combination with Peg-IFN and RBV for 12 weeks, followed by open-label Peg-IFN and RBV for an additional 12 weeks.
Overall Study Lost to Follow-up	0	1	0
Overall Study Study terminated by sponsor.	1	2	1

Baseline Characteristics

Grazoprevir (MK-5172) With Peg-Interferon and Ribavirin in Participants With Chronic Genotype 2 or 3 Hepatitis C (MK-5172-012)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Grazoprevir 400 mg + Peg-IFN + RBV n=2 Participants Grazoprevir 400 mg once daily by mouth in combination with Peg-IFN and RBV for 12 weeks.	Placebo + Peg-IFN + RBV n=1 Participants Placebo to grazoprevir once daily by mouth in combination with Peg-IFN and RBV for 12 weeks, followed by open-label Peg-IFN and RBV for an additional 12 weeks.	Total n=3 Participants Total of all reporting groups
Age, Continuous	40.5 years STANDARD_DEVIATION 7.8 • n=5 Participants	51.0 years STANDARD_DEVIATION 0.0 • n=7 Participants	44.0 years STANDARD_DEVIATION 8.2 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 12

Population: The Full Analysis Set (FAS) population includes all randomized participants who received at least 1 dose of study treatment. No participants completed treatment, and no analyses were conducted for this study due to early termination.

cEVR was defined as undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12. HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v.2.0 assay.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to Week 12 for Grazoprevir treatment arms, Week 24 for Placebo arm

Time to first achievement of undetectable HCV RNA was determined by measuring HCV RNA at Treatment Days 1, 3, and 7; Treatment Weeks 2, 4, 8, 12, 16, 20, and 24; as well as Follow-up Weeks 4, 12, and 24. HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 4

RVR was defined as undetectable HCV RNA at Week 4. HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 24 for Grazoprevir treatment arms, Week 36 for Placebo arm

SVR12 was defined as undetectable HCV RNA 12 weeks after completion of study therapy. HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 36 for Grazoprevir treatment arms, Week 48 for Placebo arm

SVR24 was defined as undetectable HCV RNA 24 weeks after completion of study therapy. HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 12

HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 24

cEVR was defined as undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 24 (i.e., after 12 weeks of placebo + 12 weeks of grazoprevir treatment). HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.

Outcome measures

Outcome data not reported

Adverse Events

Grazoprevir 400 mg + Peg-IFN + RBV

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo + Peg-IFN + RBV

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

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.
Publication restrictions are in place

Restriction type: OTHER

Measure	Grazoprevir 400 mg + Peg-IFN + RBV n=2 participants at risk Grazoprevir 400 mg once daily by mouth in combination with Peg-IFN and RBV for 12 weeks.	Placebo + Peg-IFN + RBV n=1 participants at risk Placebo to grazoprevir once daily by mouth in combination with Peg-IFN and RBV for 12 weeks, followed by open-label Peg-IFN and RBV for an additional 12 weeks.
Blood and lymphatic system disorders Anaemia	50.0% 1/2 • Number of events 1 • Non-serious AEs were collected up to Week 26 and serious AEs (SAEs) were collected up to Week 48.	0.00% 0/1 • Non-serious AEs were collected up to Week 26 and serious AEs (SAEs) were collected up to Week 48.
Gastrointestinal disorders Dry mouth	50.0% 1/2 • Number of events 1 • Non-serious AEs were collected up to Week 26 and serious AEs (SAEs) were collected up to Week 48.	0.00% 0/1 • Non-serious AEs were collected up to Week 26 and serious AEs (SAEs) were collected up to Week 48.
Gastrointestinal disorders Nausea	100.0% 2/2 • Number of events 2 • Non-serious AEs were collected up to Week 26 and serious AEs (SAEs) were collected up to Week 48.	0.00% 0/1 • Non-serious AEs were collected up to Week 26 and serious AEs (SAEs) were collected up to Week 48.
General disorders Chills	50.0% 1/2 • Number of events 1 • Non-serious AEs were collected up to Week 26 and serious AEs (SAEs) were collected up to Week 48.	100.0% 1/1 • Number of events 1 • Non-serious AEs were collected up to Week 26 and serious AEs (SAEs) were collected up to Week 48.
General disorders Fatigue	0.00% 0/2 • Non-serious AEs were collected up to Week 26 and serious AEs (SAEs) were collected up to Week 48.	100.0% 1/1 • Number of events 1 • Non-serious AEs were collected up to Week 26 and serious AEs (SAEs) were collected up to Week 48.
General disorders Injection site reaction	0.00% 0/2 • Non-serious AEs were collected up to Week 26 and serious AEs (SAEs) were collected up to Week 48.	100.0% 1/1 • Number of events 1 • Non-serious AEs were collected up to Week 26 and serious AEs (SAEs) were collected up to Week 48.
General disorders Irritabilty	0.00% 0/2 • Non-serious AEs were collected up to Week 26 and serious AEs (SAEs) were collected up to Week 48.	100.0% 1/1 • Number of events 1 • Non-serious AEs were collected up to Week 26 and serious AEs (SAEs) were collected up to Week 48.
General disorders Pyrexia	50.0% 1/2 • Number of events 1 • Non-serious AEs were collected up to Week 26 and serious AEs (SAEs) were collected up to Week 48.	0.00% 0/1 • Non-serious AEs were collected up to Week 26 and serious AEs (SAEs) were collected up to Week 48.
Infections and infestations Fungal infection	0.00% 0/2 • Non-serious AEs were collected up to Week 26 and serious AEs (SAEs) were collected up to Week 48.	100.0% 1/1 • Number of events 1 • Non-serious AEs were collected up to Week 26 and serious AEs (SAEs) were collected up to Week 48.
Infections and infestations Localised infection	0.00% 0/2 • Non-serious AEs were collected up to Week 26 and serious AEs (SAEs) were collected up to Week 48.	100.0% 1/1 • Number of events 1 • Non-serious AEs were collected up to Week 26 and serious AEs (SAEs) were collected up to Week 48.
Injury, poisoning and procedural complications Skeletal injury	0.00% 0/2 • Non-serious AEs were collected up to Week 26 and serious AEs (SAEs) were collected up to Week 48.	100.0% 1/1 • Number of events 1 • Non-serious AEs were collected up to Week 26 and serious AEs (SAEs) were collected up to Week 48.
Metabolism and nutrition disorders Decreased appetite	50.0% 1/2 • Number of events 1 • Non-serious AEs were collected up to Week 26 and serious AEs (SAEs) were collected up to Week 48.	0.00% 0/1 • Non-serious AEs were collected up to Week 26 and serious AEs (SAEs) were collected up to Week 48.
Musculoskeletal and connective tissue disorders Bone pain	50.0% 1/2 • Number of events 1 • Non-serious AEs were collected up to Week 26 and serious AEs (SAEs) were collected up to Week 48.	0.00% 0/1 • Non-serious AEs were collected up to Week 26 and serious AEs (SAEs) were collected up to Week 48.
Musculoskeletal and connective tissue disorders Myalgia	50.0% 1/2 • Number of events 1 • Non-serious AEs were collected up to Week 26 and serious AEs (SAEs) were collected up to Week 48.	100.0% 1/1 • Number of events 1 • Non-serious AEs were collected up to Week 26 and serious AEs (SAEs) were collected up to Week 48.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/2 • Non-serious AEs were collected up to Week 26 and serious AEs (SAEs) were collected up to Week 48.	100.0% 1/1 • Number of events 1 • Non-serious AEs were collected up to Week 26 and serious AEs (SAEs) were collected up to Week 48.
Nervous system disorders Headache	100.0% 2/2 • Number of events 2 • Non-serious AEs were collected up to Week 26 and serious AEs (SAEs) were collected up to Week 48.	100.0% 1/1 • Number of events 1 • Non-serious AEs were collected up to Week 26 and serious AEs (SAEs) were collected up to Week 48.
Nervous system disorders Restless leg syndrome	0.00% 0/2 • Non-serious AEs were collected up to Week 26 and serious AEs (SAEs) were collected up to Week 48.	100.0% 1/1 • Number of events 1 • Non-serious AEs were collected up to Week 26 and serious AEs (SAEs) were collected up to Week 48.
Psychiatric disorders Depression	50.0% 1/2 • Number of events 1 • Non-serious AEs were collected up to Week 26 and serious AEs (SAEs) were collected up to Week 48.	0.00% 0/1 • Non-serious AEs were collected up to Week 26 and serious AEs (SAEs) were collected up to Week 48.
Psychiatric disorders Insomnia	50.0% 1/2 • Number of events 1 • Non-serious AEs were collected up to Week 26 and serious AEs (SAEs) were collected up to Week 48.	0.00% 0/1 • Non-serious AEs were collected up to Week 26 and serious AEs (SAEs) were collected up to Week 48.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/2 • Non-serious AEs were collected up to Week 26 and serious AEs (SAEs) were collected up to Week 48.	100.0% 1/1 • Number of events 1 • Non-serious AEs were collected up to Week 26 and serious AEs (SAEs) were collected up to Week 48.
Skin and subcutaneous tissue disorders Eczema	50.0% 1/2 • Number of events 1 • Non-serious AEs were collected up to Week 26 and serious AEs (SAEs) were collected up to Week 48.	0.00% 0/1 • Non-serious AEs were collected up to Week 26 and serious AEs (SAEs) were collected up to Week 48.
Skin and subcutaneous tissue disorders Night sweats	50.0% 1/2 • Number of events 1 • Non-serious AEs were collected up to Week 26 and serious AEs (SAEs) were collected up to Week 48.	0.00% 0/1 • Non-serious AEs were collected up to Week 26 and serious AEs (SAEs) were collected up to Week 48.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/2 • Non-serious AEs were collected up to Week 26 and serious AEs (SAEs) were collected up to Week 48.	100.0% 1/1 • Number of events 1 • Non-serious AEs were collected up to Week 26 and serious AEs (SAEs) were collected up to Week 48.
Skin and subcutaneous tissue disorders Rash	0.00% 0/2 • Non-serious AEs were collected up to Week 26 and serious AEs (SAEs) were collected up to Week 48.	100.0% 1/1 • Number of events 1 • Non-serious AEs were collected up to Week 26 and serious AEs (SAEs) were collected up to Week 48.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/2 • Non-serious AEs were collected up to Week 26 and serious AEs (SAEs) were collected up to Week 48.	100.0% 1/1 • Number of events 1 • Non-serious AEs were collected up to Week 26 and serious AEs (SAEs) were collected up to Week 48.