Trial Outcomes & Findings for A Study of Different Doses of Grazoprevir (MK-5172) Given With Pegylated Interferon Alfa-2b and Ribavirin to Treatment-Naïve Participants With Chronic Hepatitis C (MK-5172-038) (NCT NCT01710501)

Last Updated: 2021-02-04

Results Overview

Hepatitis C virus ribonucleic acid (HCV RNA) was measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay, which has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. SVR12 was defined as HCV RNA \<25 IU/mL (either target detected, unquantifiable or target not detected) 12 weeks after the end of all study therapy.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

87 participants

Primary outcome timeframe

12 weeks after end of treatment (up to 36 weeks total)

Results posted on

2021-02-04

Participant Flow

Of 136 screened participants, 87 were randomized to treatment at 19 sites worldwide.

Participant milestones

Participant milestones
Measure	Grazoprevir 25 mg + PEG-IFN + RBV After a maximum of a 45 day screening window, randomized participants received 25 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.	Grazoprevir 50 mg + PEG-IFN + RBV After a maximum of a 45 day screening window, randomized participants received 50 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.	Grazoprevir 100 mg + PEG-IFN + RBV After a maximum of a 45 day screening window, randomized participants received 100 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
Overall Study STARTED	29	28	30
Overall Study COMPLETED	27	28	30
Overall Study NOT COMPLETED	2	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Grazoprevir 25 mg + PEG-IFN + RBV After a maximum of a 45 day screening window, randomized participants received 25 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.	Grazoprevir 50 mg + PEG-IFN + RBV After a maximum of a 45 day screening window, randomized participants received 50 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.	Grazoprevir 100 mg + PEG-IFN + RBV After a maximum of a 45 day screening window, randomized participants received 100 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
Overall Study Lost to Follow-up	2	0	0

Baseline Characteristics

A Study of Different Doses of Grazoprevir (MK-5172) Given With Pegylated Interferon Alfa-2b and Ribavirin to Treatment-Naïve Participants With Chronic Hepatitis C (MK-5172-038)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Grazoprevir 25 mg + PEG-IFN + RBV n=29 Participants After a maximum of a 45 day screening window, randomized participants received 25 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.	Grazoprevir 50 mg + PEG-IFN + RBV n=28 Participants After a maximum of a 45 day screening window, randomized participants received 50 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.	Grazoprevir 100 mg + PEG-IFN + RBV n=30 Participants After a maximum of a 45 day screening window, randomized participants received 100 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.	Total n=87 Participants Total of all reporting groups
Age, Continuous	52.0 years STANDARD_DEVIATION 7.9 • n=5 Participants	48.5 years STANDARD_DEVIATION 12.5 • n=7 Participants	46.4 years STANDARD_DEVIATION 13.3 • n=5 Participants	48.9 years STANDARD_DEVIATION 11.6 • n=4 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	18 Participants n=7 Participants	15 Participants n=5 Participants	41 Participants n=4 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	10 Participants n=7 Participants	15 Participants n=5 Participants	46 Participants n=4 Participants

PRIMARY outcome

Timeframe: 12 weeks after end of treatment (up to 36 weeks total)

Population: Participants in the Per-Protocol (PP) Population (all randomized participants receiving ≥1 dose of study treatment and no important protocol deviation) with available data.

Outcome measures

Outcome measures
Measure	Grazoprevir 25 mg + PEG-IFN + RBV n=24 Participants After a maximum of a 45 day screening window, randomized participants received 25 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.	Grazoprevir 50 mg + PEG-IFN + RBV n=25 Participants After a maximum of a 45 day screening window, randomized participants received 50 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.	Grazoprevir 100 mg + PEG-IFN + RBV n=26 Participants After a maximum of a 45 day screening window, randomized participants received 100 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
Percentage of Participants Achieving Sustained Virologic Response at 12 Weeks After the End of Treatment (SVR12)	54.2 percentage of participants Interval 32.8 to 74.4	84.0 percentage of participants Interval 63.9 to 95.5	88.5 percentage of participants Interval 69.8 to 97.6

PRIMARY outcome

Timeframe: 14 days following last dose of study drug (up to 26 weeks)

Population: All Participants as Treated (APaT) Population; all randomized participants who received at least one dose of study treatment.

An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol -specified procedure, whether or not considered related to the medicinal product or protocol -specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event.

Outcome measures

Outcome measures
Measure	Grazoprevir 25 mg + PEG-IFN + RBV n=29 Participants After a maximum of a 45 day screening window, randomized participants received 25 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.	Grazoprevir 50 mg + PEG-IFN + RBV n=28 Participants After a maximum of a 45 day screening window, randomized participants received 50 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.	Grazoprevir 100 mg + PEG-IFN + RBV n=30 Participants After a maximum of a 45 day screening window, randomized participants received 100 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
Number of Participants Experiencing at Least One Adverse Event (AE) During the Treatment Period and First 14 Follow-up Days	28 participants	28 participants	28 participants

PRIMARY outcome

Timeframe: Up to 24 weeks

Population: APaT Population; all randomized participants who received at least one dose of study treatment.

An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol -specified procedure, whether or not considered related to the medicinal product or protocol -specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event.

Outcome measures

Outcome measures
Measure	Grazoprevir 25 mg + PEG-IFN + RBV n=29 Participants After a maximum of a 45 day screening window, randomized participants received 25 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.	Grazoprevir 50 mg + PEG-IFN + RBV n=28 Participants After a maximum of a 45 day screening window, randomized participants received 50 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.	Grazoprevir 100 mg + PEG-IFN + RBV n=30 Participants After a maximum of a 45 day screening window, randomized participants received 100 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
Number of Participants Discontinued From Study Treatment Due to AEs During the Treatment Period and First 14 Follow-up Days	1 participants	1 participants	1 participants

SECONDARY outcome

Timeframe: From Treatment Week (TW) 2 through end of treatment (up to 24 weeks)

Population: Participants in the PP Population (all randomized participants receiving ≥1 dose of study treatment and no important protocol deviation) with available data.

HCV RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay on blood samples drawn from each participant at Week 2, Week 4, Week 12, and at end of treatment. The assay has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. Undetectable HCV RNA was defined as HCV RNA \< 9.3 IU/mL.

Outcome measures

Outcome measures
Measure	Grazoprevir 25 mg + PEG-IFN + RBV n=29 Participants After a maximum of a 45 day screening window, randomized participants received 25 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.	Grazoprevir 50 mg + PEG-IFN + RBV n=26 Participants After a maximum of a 45 day screening window, randomized participants received 50 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.	Grazoprevir 100 mg + PEG-IFN + RBV n=29 Participants After a maximum of a 45 day screening window, randomized participants received 100 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
Percentage of Participants Achieving Undetectable HCV RNA During Treatment by Time Point Week 4 (n=28, 26, 29)	82.1 percentage of participants Interval 63.1 to 93.9	76.9 percentage of participants Interval 56.4 to 91.0	89.7 percentage of participants Interval 72.6 to 97.8
Percentage of Participants Achieving Undetectable HCV RNA During Treatment by Time Point End of All Therapy (n=26, 25, 26)	92.3 percentage of participants Interval 74.9 to 99.1	92.0 percentage of participants Interval 74.0 to 99.0	100.0 percentage of participants Interval 86.8 to 100.0
Percentage of Participants Achieving Undetectable HCV RNA During Treatment by Time Point Week 2 (n=29, 25, 29)	34.5 percentage of participants Interval 17.9 to 54.3	32.0 percentage of participants Interval 14.9 to 53.5	55.2 percentage of participants Interval 35.7 to 73.6
Percentage of Participants Achieving Undetectable HCV RNA During Treatment by Time Point Week 12 (n=28, 26, 28)	96.4 percentage of participants Interval 81.7 to 99.9	92.3 percentage of participants Interval 74.9 to 99.1	100.0 percentage of participants Interval 87.7 to 100.0

SECONDARY outcome

Timeframe: From TW 2 through end of treatment (up to 24 weeks)

Population: Participants in the PP Population (all randomized participants receiving ≥1 dose of study treatment and no important protocol deviation) with available data.

Outcome measures

Outcome measures
Measure	Grazoprevir 25 mg + PEG-IFN + RBV n=29 Participants After a maximum of a 45 day screening window, randomized participants received 25 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.	Grazoprevir 50 mg + PEG-IFN + RBV n=26 Participants After a maximum of a 45 day screening window, randomized participants received 50 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.	Grazoprevir 100 mg + PEG-IFN + RBV n=29 Participants After a maximum of a 45 day screening window, randomized participants received 100 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
Percentage of Participants Achieving HCV RNA <25 IU/mL During Treatment by Time Point Week 4 (n=28, 26, 29)	96.4 percentage of participants Interval 81.7 to 99.9	100.0 percentage of participants Interval 86.8 to 100.0	100.0 percentage of participants Interval 88.1 to 100.0
Percentage of Participants Achieving HCV RNA <25 IU/mL During Treatment by Time Point Week 2 (n=29, 25, 29)	86.2 percentage of participants Interval 68.3 to 96.1	88.0 percentage of participants Interval 68.8 to 97.5	96.6 percentage of participants Interval 82.2 to 99.9
Percentage of Participants Achieving HCV RNA <25 IU/mL During Treatment by Time Point Week 12 (n=28, 26, 28)	96.4 percentage of participants Interval 81.7 to 99.9	100.0 percentage of participants Interval 86.8 to 100.0	100.0 percentage of participants Interval 87.7 to 100.0
Percentage of Participants Achieving HCV RNA <25 IU/mL During Treatment by Time Point End of all Therapy (n=26, 25, 26)	92.3 percentage of participants Interval 74.9 to 99.1	100.0 percentage of participants Interval 86.3 to 100.0	100.0 percentage of participants Interval 86.8 to 100.0

SECONDARY outcome

Timeframe: 4 weeks after end of treatment (up to 28 weeks total)

Population: Participants in the PP Population (all randomized participants receiving ≥1 dose of study treatment and no important protocol deviation) with available data.

HCV RNA was measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay, which has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. SVR4 was defined as HCV RNA \<25 IU/mL (either target detected, unquantifiable or target not detected) 4 weeks after the end of all study therapy.

Outcome measures

Outcome measures
Measure	Grazoprevir 25 mg + PEG-IFN + RBV n=26 Participants After a maximum of a 45 day screening window, randomized participants received 25 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.	Grazoprevir 50 mg + PEG-IFN + RBV n=25 Participants After a maximum of a 45 day screening window, randomized participants received 50 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.	Grazoprevir 100 mg + PEG-IFN + RBV n=26 Participants After a maximum of a 45 day screening window, randomized participants received 100 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
Percentage of Participants Achieving SVR4	76.9 percentage of participants Interval 56.4 to 91.0	88.0 percentage of participants Interval 68.8 to 97.5	92.3 percentage of participants Interval 74.9 to 99.1

SECONDARY outcome

Timeframe: 24 weeks after end of treatment (up to 48 weeks total)

Population: Participants in the PP Population (all randomized participants receiving ≥1 dose of study treatment and no important protocol deviation) with available data.

HCV RNA was measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay, which has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. SVR24 was defined as HCV RNA \<25 IU/mL (either target detected, unquantifiable or target not detected) 24 weeks after the end of all study therapy.

Outcome measures

Outcome measures
Measure	Grazoprevir 25 mg + PEG-IFN + RBV n=24 Participants After a maximum of a 45 day screening window, randomized participants received 25 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.	Grazoprevir 50 mg + PEG-IFN + RBV n=25 Participants After a maximum of a 45 day screening window, randomized participants received 50 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.	Grazoprevir 100 mg + PEG-IFN + RBV n=26 Participants After a maximum of a 45 day screening window, randomized participants received 100 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
Percentage of Subjects Achieving SVR24	54.2 percentage of participants Interval 32.8 to 74.4	84.0 percentage of participants Interval 63.9 to 95.5	84.6 percentage of participants Interval 65.1 to 95.6

SECONDARY outcome

Timeframe: From Day 1 up to Follow-up Week 24 (up to 48 weeks total)

Population: Treated non-SVR24 participants with BL and post-BL samples sequenced for RAVs.

Post-baseline resistance associated variants (RAV) analysis was conducted by comparing the amino acid sequences at virologic failure time points to those at baseline (BL): Day 1, pre-dose. A post-BL variant was defined as an amino acid substitution within HCV NS3/4A that was present after the first dose at virologic failure and follow-up visits but not at BL. Post-BL variant analysis was conducted for participants who did not achieve SVR24 who had sequence data available.

Outcome measures

Outcome measures
Measure	Grazoprevir 25 mg + PEG-IFN + RBV n=12 Participants After a maximum of a 45 day screening window, randomized participants received 25 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.	Grazoprevir 50 mg + PEG-IFN + RBV n=7 Participants After a maximum of a 45 day screening window, randomized participants received 50 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.	Grazoprevir 100 mg + PEG-IFN + RBV n=4 Participants After a maximum of a 45 day screening window, randomized participants received 100 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
Number of Participants Developing Post-baseline Antiviral Resistance to Grazoprevir Among Participants Not Achieving SVR24 Response	9 participants	5 participants	3 participants

Adverse Events

Grazoprevir 25 mg + PEG-IFN + RBV

Serious events: 1 serious events

Other events: 28 other events

Deaths: 0 deaths

Grazoprevir 50 mg + PEG-IFN + RBV

Serious events: 2 serious events

Other events: 28 other events

Deaths: 0 deaths

Grazoprevir 100 mg + PEG-IFN + RBV

Serious events: 0 serious events

Other events: 27 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Grazoprevir 25 mg + PEG-IFN + RBV n=29 participants at risk After a maximum of a 45 day screening window, randomized participants received 25 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.	Grazoprevir 50 mg + PEG-IFN + RBV n=28 participants at risk After a maximum of a 45 day screening window, randomized participants received 50 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.	Grazoprevir 100 mg + PEG-IFN + RBV n=30 participants at risk After a maximum of a 45 day screening window, randomized participants received 100 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
Gastrointestinal disorders Abdominal pain	0.00% 0/29 • From 1st day of treatment (Day 1) through Follow-up Week 24 (up to 48 weeks) AEs were reported for the APaT Population (all randomized participants who received at least one dose of study treatment) during the treatment period and entire follow-up period.	3.6% 1/28 • Number of events 1 • From 1st day of treatment (Day 1) through Follow-up Week 24 (up to 48 weeks) AEs were reported for the APaT Population (all randomized participants who received at least one dose of study treatment) during the treatment period and entire follow-up period.	0.00% 0/30 • From 1st day of treatment (Day 1) through Follow-up Week 24 (up to 48 weeks) AEs were reported for the APaT Population (all randomized participants who received at least one dose of study treatment) during the treatment period and entire follow-up period.
Hepatobiliary disorders Cholecystitis	3.4% 1/29 • Number of events 1 • From 1st day of treatment (Day 1) through Follow-up Week 24 (up to 48 weeks) AEs were reported for the APaT Population (all randomized participants who received at least one dose of study treatment) during the treatment period and entire follow-up period.	0.00% 0/28 • From 1st day of treatment (Day 1) through Follow-up Week 24 (up to 48 weeks) AEs were reported for the APaT Population (all randomized participants who received at least one dose of study treatment) during the treatment period and entire follow-up period.	0.00% 0/30 • From 1st day of treatment (Day 1) through Follow-up Week 24 (up to 48 weeks) AEs were reported for the APaT Population (all randomized participants who received at least one dose of study treatment) during the treatment period and entire follow-up period.
Cardiac disorders Acute myocardial infarction	0.00% 0/29 • From 1st day of treatment (Day 1) through Follow-up Week 24 (up to 48 weeks) AEs were reported for the APaT Population (all randomized participants who received at least one dose of study treatment) during the treatment period and entire follow-up period.	3.6% 1/28 • Number of events 1 • From 1st day of treatment (Day 1) through Follow-up Week 24 (up to 48 weeks) AEs were reported for the APaT Population (all randomized participants who received at least one dose of study treatment) during the treatment period and entire follow-up period.	0.00% 0/30 • From 1st day of treatment (Day 1) through Follow-up Week 24 (up to 48 weeks) AEs were reported for the APaT Population (all randomized participants who received at least one dose of study treatment) during the treatment period and entire follow-up period.

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 trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
Publication restrictions are in place

Restriction type: OTHER