Efficacy and Safety of Elbasvir (MK-8742) + Grazoprevir (MK-5172) in Treatment-Naïve/Treatment-Experienced (TN/TE) French Participants With Hepatitis C Virus (HCV) Genotype 4 (GT4) Infection (MK-5172-096)
Study Details
Study Description
Brief Summary
The purpose of this study was to evaluate the efficacy of 8 and 12 weeks of treatment with a fixed dose combination (FDC) of elbasvir (EBR) 50 mg + grazoprevir (GZR) 100 mg (i.e., MK-5172A) as assessed by the percentage of participants with hepatitis C virus (HCV) genotype (GT) 4 infection that achieve sustained virologic response (HCV ribonucleic acid [RNA] < Lower Limit of Quantification [LLOQ]) 12 weeks after the end of study therapy (SVR12). This study also evaluated the safety and tolerability of EBR/GZR.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Arm 1: EBR/GZR for 8 Weeks Treatment-naïve participants with stage 0-2 fibrosis (F0-F2) receive FDC of EBR/GZR (50 mg/100 mg) for 8 weeks, with 24 weeks of follow-up. |
Drug: EBR/GZR (50 mg/100 mg) FDC
One FDC tablet taken once daily by mouth for 8 or 12 weeks depending upon randomization.
Other Names:
|
| Experimental: Arm 2: EBR/GZR for 12 Weeks Treatment-naïve participants with F0-F2 stage fibrosis, treatment-naïve participants with F3-F4 stage fibrosis, and treatment-experienced participants with F0-F4 stage fibrosis receive FDC of EBR/GZR (50 mg/100 mg) for 12 weeks, with 24 weeks of follow-up. |
Drug: EBR/GZR (50 mg/100 mg) FDC
One FDC tablet taken once daily by mouth for 8 or 12 weeks depending upon randomization.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After End of Treatment (SVR12) [12 weeks after completing study treatment (Arm 1: Week 20 / Arm 2: Week 24)]
The percentage of participants to achieve SVR12 was determined for each arm (SVR12 was defined as HCV ribonucleic acid [RNA] < lower limit of quantification [LLOQ] at 12 weeks after the end of all study therapy). Plasma HCV RNA was measured using the COBAS™ AmpliPrep/COBAS™ TaqMan HCV Test, v2.0®, which has a LLOQ of 15 IU/mL.
- Number of Participants With ≥ 1 Adverse Events (AEs) [Up to 14 weeks]
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
- Number of Participants Who Discontinued From Study Treatment Due to an AE [Up to Study Week 12]
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Secondary Outcome Measures
- Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After End of Treatment (SVR24) [24 weeks after completing study treatment (Arm 1: Week 32 / Arm 2: Week 36)]
The percentage of participants to achieve SVR24 was determined for each arm (SVR24 was defined as HCV RNA < LLOQ at 24 weeks after the end of all study therapy). Plasma HCV RNA was measured using the COBAS™ AmpliPrep/COBAS™ TaqMan HCV Test, v2.0®, which has a LLOQ of 15 IU/mL.
- Prevalence of Baseline NS3 Resistance-Associated Substitutions (RASs) to EBR or GZR [Day 1]
Blood samples for viral resistance assays were collected at Baseline (Day 1) and analyzed for substitutions in the NS3 gene region. Results are pooled for all participants with baseline sequencing data available, and the number of participants with RASs is reported according HCV genotype. Resistance-associated substitutions are defined as amino acid substitutions that confer reduced susceptibility to a direct-acting antiviral (DAA) and may contribute to virologic failure. The prevalence of baseline substitutions in participants infected with HCV GT4 subtypes was assessed by evaluating amino acid substitutions in NS3.
- Prevalence of Baseline NS5A RASs to EBR or GZR [Day 1]
Blood samples for viral resistance assays were collected at Baseline (Day 1) and analyzed for substitutions in the NS5A gene region. Results are pooled for all participants with baseline sequencing data available, and the number of participants with RASs is reported according HCV genotype. Resistance-associated substitutions are defined as amino acid substitutions that confer reduced susceptibility to a DAA and may contribute to virologic failure. The prevalence of baseline substitutions in participants infected with HCV GT4 subtypes was assessed by evaluating amino acid substitutions in NS5A.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Be a current resident of France
-
Have HCV RNA (≥ 10,000 IU/mL in peripheral blood) at the time of screening
-
Have documented chronic HCV GT4 (with no evidence of non-typeable or mixed genotype) infection
-
Have liver biopsy performed within 24 months of Day 1 of this study (if participant has cirrhosis, there is no time restriction on biopsy), or have FibroScan® performed within 12 months of Day 1 of this study with interpretable result in kilopascals (kPa) as follows: Fibrosis score of F0-F2, Fibrosis score of F3, or Cirrhosis (F4)
-
Have a prior treatment history of either HCV TN or HCV TE with interferon (IFN) +/- ribavirin (RBV) +/- Sofosbuvir (SOF) (on-treatment failure, relapser, or other/intolerant)
-
Females who are of reproductive potential must agree to avoid becoming pregnant while receiving study drug and for 14 days after the last dose of study drug by complying with one of the following: (1) practice abstinence from heterosexual activity OR (2) use (or have her partner use) acceptable contraception during heterosexual activity
-
If Human Immunodeficiency Virus (HIV) co-infected, then have HIV-1 infection documented prior to screening
Exclusion Criteria:
-
Had prior treatment (defined as 1 dose or more) with direct-acting antiviral (DAA) therapy
-
Has evidence of decompensated liver disease manifested by the presence of or history of ascites, esophageal or gastric variceal bleeding, hepatic encephalopathy, or other signs or symptoms of active advanced liver disease
-
Classified as Child-Pugh B or C or has a Child Pugh-Turcotte score (CPT) > 6
-
Has cirrhosis and liver imaging within 6 months of Day 1 showing evidence of hepatocellular carcinoma (HCC) or is under evaluation for HCC
-
Hepatitis B virus surface antigen (HBsAg) positive at screening. Participants who are HBsAg negative and hepatitis B core antibody (anti-HBc) positive at screening may be included
-
Under evaluation for active or suspected malignancy, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer Currently participating or has participated in a study with an investigational compound within 30 days of signing informed consent and is not willing to refrain from participating in another such study during the course of this study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHU Amiens-Picardie - Hopital Sud ( Site 0217) | Amiens | France | ||
| 2 | CHU Jean Minjoz ( Site 0213) | Besancon | France | ||
| 3 | CHU Henri Mondor ( Site 0206) | Creteil | France | ||
| 4 | CHU de Grenoble - Hopital Michallon ( Site 0208) | Genoble | France | ||
| 5 | CHU Dupuytren ( Site 0209) | Limoges | France | ||
| 6 | Hopital Saint Eloi ( Site 0207) | Montpellier | France | ||
| 7 | C.H.U. de Nice Hopital de l Archet 2 ( Site 0215) | Nice | France | ||
| 8 | Centre Hospitalier Regional du Orleans ( Site 0212) | Orleans | France | ||
| 9 | Hopital Beaujon ( Site 0201) | Paris | France | ||
| 10 | Hopital Cochin ( Site 0211) | Paris | France | ||
| 11 | Hopital Saint Antoine ( Site 0200) | Paris | France | ||
| 12 | CHU de Toulouse - Hopital Purpan ( Site 0216) | Toulouse | France | ||
| 13 | CHU de Nancy Hopital Brabois Adultes ( Site 0204) | Vandoeuvre les Nancy | France |
Sponsors and Collaborators
- Merck Sharp & Dohme LLC
Investigators
- Study Director: Medical Director, Merck Sharp & Dohme LLC
Study Documents (Full-Text)
More Information
Publications
None provided.- 5172-096
- 2016-001159-37
- MK-5172-096
Study Results
Participant Flow
| Recruitment Details | Adult male and female participants with chronic hepatitis C virus (HCV) genotype 4 (GT4) infection were enrolled at 12 study centers in France. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Arm 1: EBR/GZR for 8 Weeks | Arm 2: EBR/GZR for 12 Weeks |
|---|---|---|
| Arm/Group Description | Treatment-naïve HCV GT4 participants with stage 0-2 fibrosis (F0-F2) received elbasvir/grazoprevir (EBR/GZR) fixed dose combination (FDC) [50 mg/100 mg] for 8 weeks, followed by 24 weeks of follow-up. | Treatment-naïve HCV GT4 participants with F0-F2 stage fibrosis, treatment-naïve participants with F3-F4 stage fibrosis, and treatment-experienced participants with F0-F4 stage fibrosis received EBR/GZR FDC (50 mg/100 mg) for 12 weeks, followed by 24 weeks of follow-up. |
| Period Title: Overall Study | ||
| STARTED | 53 | 64 |
| COMPLETED | 52 | 63 |
| NOT COMPLETED | 1 | 1 |
Baseline Characteristics
| Arm/Group Title | Arm 1: EBR/GZR for 8 Weeks | Arm 2: EBR/GZR for 12 Weeks | Total |
|---|---|---|---|
| Arm/Group Description | Treatment-naïve HCV GT4 participants with stage 0-2 fibrosis (F0-F2) received EBR/GZR FDC (50 mg/100 mg) for 8 weeks, followed by 24 weeks of follow-up. | Treatment-naïve HCV GT4 participants with F0-F2 stage fibrosis, treatment-naïve participants with F3-F4 stage fibrosis, and treatment-experienced participants with F0-F4 stage fibrosis received EBR/GZR FDC (50 mg/100 mg) for 12 weeks, followed by 24 weeks of follow-up. | Total of all reporting groups |
| Overall Participants | 53 | 64 | 117 |
| Age (Years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [Years] |
51.5
(12.9)
|
56.0
(9.7)
|
54.0
(11.4)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
29
54.7%
|
32
50%
|
61
52.1%
|
| Male |
24
45.3%
|
32
50%
|
56
47.9%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
1
1.9%
|
0
0%
|
1
0.9%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
20
37.7%
|
29
45.3%
|
49
41.9%
|
| White |
28
52.8%
|
29
45.3%
|
57
48.7%
|
| More than one race |
1
1.9%
|
0
0%
|
1
0.9%
|
| Unknown or Not Reported |
3
5.7%
|
6
9.4%
|
9
7.7%
|
Outcome Measures
| Title | Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After End of Treatment (SVR12) |
|---|---|
| Description | The percentage of participants to achieve SVR12 was determined for each arm (SVR12 was defined as HCV ribonucleic acid [RNA] < lower limit of quantification [LLOQ] at 12 weeks after the end of all study therapy). Plasma HCV RNA was measured using the COBAS™ AmpliPrep/COBAS™ TaqMan HCV Test, v2.0®, which has a LLOQ of 15 IU/mL. |
| Time Frame | 12 weeks after completing study treatment (Arm 1: Week 20 / Arm 2: Week 24) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants who received ≥1 dose of study treatment are included. |
| Arm/Group Title | Arm 1: EBR/GZR for 8 Weeks | Arm 2: EBR/GZR for 12 Weeks |
|---|---|---|
| Arm/Group Description | Treatment-naïve HCV GT4 participants with stage 0-2 fibrosis (F0-F2) received EBR/GZR fixed dose combination (FDC) [50 mg/100 mg] for 8 weeks, followed by 24 weeks of follow-up. | Treatment-naïve HCV GT4 participants with F0-F2 stage fibrosis, treatment-naïve participants with F3-F4 stage fibrosis, and treatment-experienced participants with F0-F4 stage fibrosis received EBR/GZR FDC (50 mg/100 mg) for 12 weeks, followed by 24 weeks of follow-up. |
| Measure Participants | 53 | 64 |
| Number (95% Confidence Interval) [Percentage of Participants] |
94.3
177.9%
|
95.3
148.9%
|
| Title | Number of Participants With ≥ 1 Adverse Events (AEs) |
|---|---|
| Description | An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. |
| Time Frame | Up to 14 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants who received ≥1 dose of study treatment are included, classified according to treatment duration actually received. |
| Arm/Group Title | Arm 1: EBR/GZR for 8 Weeks | Arm 2: EBR/GZR for 12 Weeks |
|---|---|---|
| Arm/Group Description | Treatment-naïve HCV GT4 participants with stage 0-2 fibrosis (F0-F2) received EBR/GZR fixed dose combination (FDC) [50 mg/100 mg] for 8 weeks, followed by 24 weeks of follow-up. | Treatment-naïve HCV GT4 participants with F0-F2 stage fibrosis, treatment-naïve participants with F3-F4 stage fibrosis, and treatment-experienced participants with F0-F4 stage fibrosis received EBR/GZR FDC (50 mg/100 mg) for 12 weeks, followed by 24 weeks of follow-up. |
| Measure Participants | 53 | 64 |
| Number [Participants] |
33
62.3%
|
46
71.9%
|
| Title | Number of Participants Who Discontinued From Study Treatment Due to an AE |
|---|---|
| Description | An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. |
| Time Frame | Up to Study Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants who received ≥1 dose of study treatment are included, classified according to treatment duration actually received. |
| Arm/Group Title | Arm 1: EBR/GZR for 8 Weeks | Arm 2: EBR/GZR for 12 Weeks |
|---|---|---|
| Arm/Group Description | Treatment-naïve HCV GT4 participants with stage 0-2 fibrosis (F0-F2) received EBR/GZR fixed dose combination (FDC) [50 mg/100 mg] for 8 weeks, followed by 24 weeks of follow-up. | Treatment-naïve HCV GT4 participants with F0-F2 stage fibrosis, treatment-naïve participants with F3-F4 stage fibrosis, and treatment-experienced participants with F0-F4 stage fibrosis received EBR/GZR FDC (50 mg/100 mg) for 12 weeks, followed by 24 weeks of follow-up. |
| Measure Participants | 53 | 64 |
| Number [Participants] |
0
0%
|
0
0%
|
| Title | Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After End of Treatment (SVR24) |
|---|---|
| Description | The percentage of participants to achieve SVR24 was determined for each arm (SVR24 was defined as HCV RNA < LLOQ at 24 weeks after the end of all study therapy). Plasma HCV RNA was measured using the COBAS™ AmpliPrep/COBAS™ TaqMan HCV Test, v2.0®, which has a LLOQ of 15 IU/mL. |
| Time Frame | 24 weeks after completing study treatment (Arm 1: Week 32 / Arm 2: Week 36) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants who received ≥1 dose of study treatment are included. |
| Arm/Group Title | Arm 1: EBR/GZR for 8 Weeks | Arm 2: EBR/GZR for 12 Weeks |
|---|---|---|
| Arm/Group Description | Treatment-naïve HCV GT4 participants with stage 0-2 fibrosis (F0-F2) received EBR/GZR fixed dose combination (FDC) [50 mg/100 mg] for 8 weeks, followed by 24 weeks of follow-up. | Treatment-naïve HCV GT4 participants with F0-F2 stage fibrosis, treatment-naïve participants with F3-F4 stage fibrosis, and treatment-experienced participants with F0-F4 stage fibrosis received EBR/GZR FDC (50 mg/100 mg) for 12 weeks, followed by 24 weeks of follow-up. |
| Measure Participants | 53 | 64 |
| Number (95% Confidence Interval) [Percentage of Participants] |
94.3
177.9%
|
93.8
146.6%
|
| Title | Prevalence of Baseline NS3 Resistance-Associated Substitutions (RASs) to EBR or GZR |
|---|---|
| Description | Blood samples for viral resistance assays were collected at Baseline (Day 1) and analyzed for substitutions in the NS3 gene region. Results are pooled for all participants with baseline sequencing data available, and the number of participants with RASs is reported according HCV genotype. Resistance-associated substitutions are defined as amino acid substitutions that confer reduced susceptibility to a direct-acting antiviral (DAA) and may contribute to virologic failure. The prevalence of baseline substitutions in participants infected with HCV GT4 subtypes was assessed by evaluating amino acid substitutions in NS3. |
| Time Frame | Day 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants with baseline sequencing data for NS3 are included. |
| Arm/Group Title | Arm 1: EBR/GZR for 8 Weeks | Arm 2: EBR/GZR for 12 Weeks |
|---|---|---|
| Arm/Group Description | Treatment-naïve HCV GT4 participants with stage 0-2 fibrosis (F0-F2) received EBR/GZR fixed dose combination (FDC) [50 mg/100 mg] for 8 weeks, followed by 24 weeks of follow-up. | Treatment-naïve HCV GT4 participants with F0-F2 stage fibrosis, treatment-naïve participants with F3-F4 stage fibrosis, and treatment-experienced participants with F0-F4 stage fibrosis received EBR/GZR FDC (50 mg/100 mg) for 12 weeks, followed by 24 weeks of follow-up. |
| Measure Participants | 51 | 59 |
| GT4 |
5
9.4%
|
6
9.4%
|
| GT4D |
3
5.7%
|
3
4.7%
|
| GT4-Other |
6
11.3%
|
9
14.1%
|
| Title | Prevalence of Baseline NS5A RASs to EBR or GZR |
|---|---|
| Description | Blood samples for viral resistance assays were collected at Baseline (Day 1) and analyzed for substitutions in the NS5A gene region. Results are pooled for all participants with baseline sequencing data available, and the number of participants with RASs is reported according HCV genotype. Resistance-associated substitutions are defined as amino acid substitutions that confer reduced susceptibility to a DAA and may contribute to virologic failure. The prevalence of baseline substitutions in participants infected with HCV GT4 subtypes was assessed by evaluating amino acid substitutions in NS5A. |
| Time Frame | Day 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants with baseline sequencing data for NS5A are included. |
| Arm/Group Title | Arm 1: EBR/GZR for 8 Weeks | Arm 2: EBR/GZR for 12 Weeks |
|---|---|---|
| Arm/Group Description | Treatment-naïve HCV GT4 participants with stage 0-2 fibrosis (F0-F2) received EBR/GZR fixed dose combination (FDC) [50 mg/100 mg] for 8 weeks, followed by 24 weeks of follow-up. | Treatment-naïve HCV GT4 participants with F0-F2 stage fibrosis, treatment-naïve participants with F3-F4 stage fibrosis, and treatment-experienced participants with F0-F4 stage fibrosis received EBR/GZR FDC (50 mg/100 mg) for 12 weeks, followed by 24 weeks of follow-up. |
| Measure Participants | 53 | 63 |
| GT4 |
3
5.7%
|
2
3.1%
|
| GT4D |
10
18.9%
|
16
25%
|
| GT4-Other |
13
24.5%
|
21
32.8%
|
Adverse Events
| Time Frame | Up to 36 weeks | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | All participants who received ≥1 dose of study medication are included. | |||
| Arm/Group Title | Arm 1: EBR/GZR for 8 Weeks | Arm 2: EBR/GZR for 12 Weeks | ||
| Arm/Group Description | Treatment-naïve HCV GT4 participants with stage 0-2 fibrosis (F0-F2) received EBR/GZR fixed dose combination (FDC) [50 mg/100 mg] for 8 weeks, followed by 24 weeks of follow-up. | Treatment-naïve HCV GT4 participants with F0-F2 stage fibrosis, treatment-naïve participants with F3-F4 stage fibrosis, and treatment-experienced participants with F0-F4 stage fibrosis received EBR/GZR FDC (50 mg/100 mg) for 12 weeks, followed by 24 weeks of follow-up. | ||
All Cause Mortality |
||||
| Arm 1: EBR/GZR for 8 Weeks | Arm 2: EBR/GZR for 12 Weeks | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/53 (0%) | 1/64 (1.6%) | ||
Serious Adverse Events |
||||
| Arm 1: EBR/GZR for 8 Weeks | Arm 2: EBR/GZR for 12 Weeks | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2/53 (3.8%) | 2/64 (3.1%) | ||
| Infections and infestations | ||||
| Post procedural infection | 1/53 (1.9%) | 1 | 0/64 (0%) | 0 |
| Metabolism and nutrition disorders | ||||
| Diabetes mellitus | 1/53 (1.9%) | 1 | 0/64 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||
| Osteoarthritis | 0/53 (0%) | 0 | 1/64 (1.6%) | 1 |
| Nervous system disorders | ||||
| Cerebellar stroke | 0/53 (0%) | 0 | 1/64 (1.6%) | 1 |
Other (Not Including Serious) Adverse Events |
||||
| Arm 1: EBR/GZR for 8 Weeks | Arm 2: EBR/GZR for 12 Weeks | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 27/53 (50.9%) | 38/64 (59.4%) | ||
| Gastrointestinal disorders | ||||
| Abdominal pain | 0/53 (0%) | 0 | 4/64 (6.3%) | 4 |
| Diarrhoea | 3/53 (5.7%) | 4 | 3/64 (4.7%) | 4 |
| Nausea | 4/53 (7.5%) | 4 | 4/64 (6.3%) | 5 |
| General disorders | ||||
| Asthenia | 12/53 (22.6%) | 12 | 14/64 (21.9%) | 14 |
| Fatigue | 1/53 (1.9%) | 1 | 4/64 (6.3%) | 4 |
| Infections and infestations | ||||
| Bronchitis | 3/53 (5.7%) | 3 | 1/64 (1.6%) | 1 |
| Influenza | 2/53 (3.8%) | 2 | 4/64 (6.3%) | 4 |
| Nasopharyngitis | 1/53 (1.9%) | 1 | 5/64 (7.8%) | 5 |
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia | 3/53 (5.7%) | 3 | 1/64 (1.6%) | 1 |
| Back pain | 3/53 (5.7%) | 3 | 1/64 (1.6%) | 1 |
| Nervous system disorders | ||||
| Dizziness | 3/53 (5.7%) | 4 | 1/64 (1.6%) | 1 |
| Headache | 9/53 (17%) | 10 | 16/64 (25%) | 16 |
| Psychiatric disorders | ||||
| Insomnia | 2/53 (3.8%) | 2 | 5/64 (7.8%) | 6 |
| Skin and subcutaneous tissue disorders | ||||
| Pruritus | 2/53 (3.8%) | 2 | 4/64 (6.3%) | 5 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
| Name/Title | Senior Vice President, Global Clinical Development |
|---|---|
| Organization | Merck Sharp & Dohme Corp. |
| Phone | 1-800-672-6372 |
| ClinicalTrialsDisclosure@merck.com |
- 5172-096
- 2016-001159-37
- MK-5172-096