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CompletedNCT00704184Updated Oct 9, 2018Results posted

Safety and Efficacy of Vaniprevir (MK7009) Administered With Pegylated-Interferon and Ribavirin (MK-7009-007)

A Phase 2 interventional study of Comparator: Vaniprevir and Comparator: Pegylated-Interferon (Peg-IFN) in Hepatitis C, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-10-09.

Sponsored by Merck Sharp & Dohme LLC · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
95
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

A study to evaluate how effective different levels of Vaniprevir (MK-7009), when administered with Pegylated-Interferon (Peg-IFN) and Ribavirin, are at achieving rapid viral response (RVR) i.e., undetectable hepatitis C virus [HCV] viral ribonucleic acid [RNA] at Week 4 in participants with chronic HCV infection. The primary hypothesis was that the proportion of participants in one or more of the Vaniprevir treatment groups achieving RVR would be greater than the proportion of placebo participants achieving RVR when Vaniprevir and placebo were co-administered with Peg-IFN/Ribavirin.

02

Conditions studied

  • Hepatitis C
03

In context

Hepatitis C

2,321 studies on the registry are indexed under Hepatitis C; 102 are open to participants now.

This study's enrollment of 95 is above the median of 79 across 1,633 interventional studies indexed under Hepatitis C.

Browse Hepatitis C studies →

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.

Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patient has chronic Genotype 1 Hepatitis C infection

Exclusion criteria

Exclusion Criteria:

  • Subject has been previously treated for HCV
  • Has Human Immunodeficiency Virus (HIV)
  • Has Hepatitis B
  • Has a history of clinically significant medical condition that may interfere with the study (e.g., stroke or chronic seizures or major neurological disorder) or is contraindicated for treatment with peg-IFN and Ribavirin
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
95 participants (actual)

Study arms

  • Placebo comparator
    Placebo + Peg-IFN/Ribavirin

    Participants took double-blind Placebo + Peg-IFN/Ribavirin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavirin from Week 5 to Week 48.

    Drug: Comparator: Pegylated-Interferon (Peg-IFN) · Drug: Comparator: Ribavirin

  • Experimental
    Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin

    Participants took double-blind Vaniprevir 300 mg twice daily (b.i.d.) + Peg-IFN/Ribavirin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavirin from Week 5 to Week 48.

    Drug: Comparator: Vaniprevir · Drug: Comparator: Pegylated-Interferon (Peg-IFN) · Drug: Comparator: Ribavirin

  • Experimental
    Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin

    Participants took double-blind Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavirin from Week 5 to Week 48.

    Drug: Comparator: Vaniprevir · Drug: Comparator: Pegylated-Interferon (Peg-IFN) · Drug: Comparator: Ribavirin

  • Experimental
    Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin

    Participants took double-blind Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavirin from Week 5 to Week 48.

    Drug: Comparator: Vaniprevir · Drug: Comparator: Pegylated-Interferon (Peg-IFN) · Drug: Comparator: Ribavirin

  • Experimental
    Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin

    Participants took double-blind Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavirin from Week 5 to Week 48.

    Drug: Comparator: Vaniprevir · Drug: Comparator: Pegylated-Interferon (Peg-IFN) · Drug: Comparator: Ribavirin · Drug: Comparator: placebo

Interventions

  • DrugComparator: Vaniprevir

    Vaniprevir 300 mg b.i.d., 600 mg b.i.d., 600 mg q.d., or 800 mg q.d.; duration of treatment: 28 days

    Also known as: MK-7009

  • DrugComparator: Pegylated-Interferon (Peg-IFN)

    Peg-IFN 180 mcg once-weekly subcutaneous injection; duration of treatment: 48 weeks

  • DrugComparator: Ribavirin

    Ribavirin 200 mg tablet b.i.d. (dose based on body weight); duration of treatment: 48 weeks

  • DrugComparator: placebo

    Matching placebo to vaniprevir; duration of treatment: 28 days

06

What researchers measure

Primary outcomes

  1. Percentage of Participants Achieving RVR

    Rapid Viral Response (RVR) was declared if Hepatitis C Virus (HCV) ribonucleic acid (RNA) was undetectable at Week 4.

    Time frame: Week 4

  2. Number of Participants Experiencing an Adverse Event (AE)

    The number of participants experiencing AEs in each treatment group was monitored during the Vaniprevir/Placebo treatment (Day 1 to Day 28) and safety follow-up (Day 29 to Day 42) periods.

    Time frame: Up to Day 42

  3. Number of Participants Discontinuing From Study Therapy Due to AEs

    An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of study therapy, whether or not considered related to the use of the product.

    Time frame: Day 1 to Day 28

Secondary outcomes

  1. Number of Participants With ≥2-log10 Decrease in HCV RNA

    The number of participants with at least a 2-log10 decrease from baseline in HCV RNA following 4 weeks of treatment with Placebo or Vaniprevir.

    Time frame: Baseline and Week 4

  2. Number of Participants With ≥3-log10 Decrease in HCV RNA

    The number of participants with at least a 3-log10 decrease from baseline in HCV RNA following 4 weeks of treatment with Placebo or Vaniprevir.

    Time frame: Baseline and Week 4

  3. Mean Log Change From Baseline in HCV RNA

    The mean changes from baseline in log10 HCV RNA in each vaniprevir group was compared against control treatment at Week 4.

    Time frame: Baseline and Week 4

07

Results

Posted Oct 1, 2014

Participant flow

Double-Blind Treatment
Participant flow — Double-Blind Treatment
MilestonePlacebo + Peg-IFN/RibavirinVaniprevir 300 mg b.i.d. + Peg-IFN/RibavirinVaniprevir 600 mg b.i.d. + Peg-IFN/RibavirinVaniprevir 600 mg q.d. + Peg-IFN/RibavirinVaniprevir 800 mg q.d. + Peg-IFN/Ribavirin
Started2018201819
Treated1918201819
Completed1918201819
Not completed10000
Withdrew: Withdrawal by subject10000
Open-Label Treatment
Participant flow — Open-Label Treatment
MilestonePlacebo + Peg-IFN/RibavirinVaniprevir 300 mg b.i.d. + Peg-IFN/RibavirinVaniprevir 600 mg b.i.d. + Peg-IFN/RibavirinVaniprevir 600 mg q.d. + Peg-IFN/RibavirinVaniprevir 800 mg q.d. + Peg-IFN/Ribavirin
Started1918201819
Completed1816161316
Not completed12453
Withdrew: Adverse event00201
Withdrew: Lack of efficacy02221
Withdrew: Physician decision00001
Withdrew: Withdrawal by subject10030

Outcome measures

PrimaryPercentage of Participants Achieving RVR

Rapid Viral Response (RVR) was declared if Hepatitis C Virus (HCV) ribonucleic acid (RNA) was undetectable at Week 4.

Time frame:
Week 4
Reported as:
Number · Percentage of Participants
Percentage of Participants Achieving RVR
Percentage of ParticipantsPlacebo + Peg-IFN/RibavirinVaniprevir 300 mg b.i.d. + Peg-IFN/RibavirinVaniprevir 600 mg b.i.d. + Peg-IFN/RibavirinVaniprevir 600 mg q.d. + Peg-IFN/RibavirinVaniprevir 800 mg q.d. + Peg-IFN/Ribavirin
Percentage of Participants Achieving RVR5.675.078.968.883.3
Statistical analysis
  • Placebo + Peg-IFN/Ribavirin vs Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin · Miettinen and Nurminen method · p = <0.001 · Adjusted difference in %: 69.3 · 95% CI 40.3 to 86.7Adjusted difference subtracts the percentage of placebo responders (5.3%) and stratifies by HCV genotype (1a vs. non-1a).
  • Placebo + Peg-IFN/Ribavirin vs Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin · Miettinen and Nurminen method · p = <0.001 · Adjusted difference in %: 73.6 · 95% CI 46.0 to 88.6Adjusted difference subtracts the percentage of placebo responders (5.3%) and stratifies by HCV genotype (1a vs. non-1a).
  • Placebo + Peg-IFN/Ribavirin vs Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin · Miettinen and Nurminen method · p = <0.001 · Adjusted difference in %: 63.3 · 95% CI 32.8 to 82.7Adjusted difference subtracts the percentage of placebo responders (5.3%) and stratifies by HCV genotype (1a vs. non-1a).
  • Placebo + Peg-IFN/Ribavirin vs Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin · Miettinen and Nurminen method · p = <0.001 · Adjusted difference in %: 77.8 · 95% CI 49.2 to 91.3Adjusted difference subtracts the percentage of placebo responders (5.3) and stratifies by HCV genotype (1a vs. non-1a).
PrimaryNumber of Participants Experiencing an Adverse Event (AE)

The number of participants experiencing AEs in each treatment group was monitored during the Vaniprevir/Placebo treatment (Day 1 to Day 28) and safety follow-up (Day 29 to Day 42) periods.

Time frame:
Up to Day 42
Reported as:
Number · Participants
Number of Participants Experiencing an Adverse Event (AE)
ParticipantsPlacebo + Peg-IFN/RibavirinVaniprevir 300 mg b.i.d. + Peg-IFN/RibavirinVaniprevir 600 mg b.i.d. + Peg-IFN/RibavirinVaniprevir 600 mg q.d. + Peg-IFN/RibavirinVaniprevir 800 mg q.d. + Peg-IFN/Ribavirin
Number of Participants Experiencing an Adverse Event (AE)1815181618
PrimaryNumber of Participants Discontinuing From Study Therapy Due to AEs

An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of study therapy, whether or not considered related to the use of the product.

Time frame:
Day 1 to Day 28
Reported as:
Number · Participants
Number of Participants Discontinuing From Study Therapy Due to AEs
ParticipantsPlacebo + Peg-IFN/RibavirinVaniprevir 300 mg b.i.d. + Peg-IFN/RibavirinVaniprevir 600 mg b.i.d. + Peg-IFN/RibavirinVaniprevir 600 mg q.d. + Peg-IFN/RibavirinVaniprevir 800 mg q.d. + Peg-IFN/Ribavirin
Number of Participants Discontinuing From Study Therapy Due to AEs00000
SecondaryNumber of Participants With ≥2-log10 Decrease in HCV RNA

The number of participants with at least a 2-log10 decrease from baseline in HCV RNA following 4 weeks of treatment with Placebo or Vaniprevir.

Time frame:
Baseline and Week 4
Reported as:
Number · Number of Participants
Number of Participants With ≥2-log10 Decrease in HCV RNA
Number of ParticipantsPlacebo + Peg-IFN/RibavirinVaniprevir 300 mg b.i.d. + Peg-IFN/RibavirinVaniprevir 600 mg b.i.d. + Peg-IFN/RibavirinVaniprevir 600 mg q.d. + Peg-IFN/RibavirinVaniprevir 800 mg q.d. + Peg-IFN/Ribavirin
Number of Participants With ≥2-log10 Decrease in HCV RNA1616191617
Statistical analysis
  • Placebo + Peg-IFN/Ribavirin vs Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin · Adjusted difference: 11.2 · 95% CI -9.7 to 33.8Adjusted difference subtracts the percentage of placebo responders (88.9%) and stratifies by HCV genotype (1a vs. non-1a).
  • Placebo + Peg-IFN/Ribavirin vs Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin · Adjusted difference: 10.8 · 95% CI -7.6 to 33.2Adjusted difference subtracts the percentage of placebo responders (88.9%) and stratifies by HCV genotype (1a vs. non-1a).
  • Placebo + Peg-IFN/Ribavirin vs Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin · Adjusted difference: 11.2 · 95% CI -9.7 to 33.8Adjusted difference subtracts the percentage of placebo responders (88.9%) and stratifies by HCV genotype (1a vs. non-1a).
  • Placebo + Peg-IFN/Ribavirin vs Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin · Adjusted difference: 5.4 · 95% CI -16.5 to 28.4Adjusted difference subtracts the percentage of placebo responders (88.9%) and stratifies by HCV genotype (1a vs. non-1a).
SecondaryNumber of Participants With ≥3-log10 Decrease in HCV RNA

The number of participants with at least a 3-log10 decrease from baseline in HCV RNA following 4 weeks of treatment with Placebo or Vaniprevir.

Time frame:
Baseline and Week 4
Reported as:
Number · Number of Participants
Number of Participants With ≥3-log10 Decrease in HCV RNA
Number of ParticipantsPlacebo + Peg-IFN/RibavirinVaniprevir 300 mg b.i.d. + Peg-IFN/RibavirinVaniprevir 600 mg b.i.d. + Peg-IFN/RibavirinVaniprevir 600 mg q.d. + Peg-IFN/RibavirinVaniprevir 800 mg q.d. + Peg-IFN/Ribavirin
Number of Participants With ≥3-log10 Decrease in HCV RNA1516191617
Statistical analysis
  • Placebo + Peg-IFN/Ribavirin vs Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin · Adjusted difference: 16.9 · 95% CI -4.0 to 40.2Adjusted difference subtracts the percentage of placebo responders (83.3%) and stratifies by HCV genotype (1a vs. non-1a).
  • Placebo + Peg-IFN/Ribavirin vs Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin · Adjusted difference: 16.2 · 95% CI -2.2 to 39.5Adjusted difference subtracts the percentage of placebo responders (83.3%) and stratifies by HCV genotype (1a vs. non-1a).
  • Placebo + Peg-IFN/Ribavirin vs Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin · Adjusted difference: 16.9 · 95% CI -4.0 to 40.2Adjusted difference subtracts the percentage of placebo responders (83.3%) and stratifies by HCV genotype (1a vs. non-1a).
  • Placebo + Peg-IFN/Ribavirin vs Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin · Adjusted difference: 10.7 · 95% CI -11.4 to 34.6Adjusted difference subtracts the percentage of placebo responders (83.3%) and stratifies by HCV genotype (1a vs. non-1a).
SecondaryMean Log Change From Baseline in HCV RNA

The mean changes from baseline in log10 HCV RNA in each vaniprevir group was compared against control treatment at Week 4.

Time frame:
Baseline and Week 4
Reported as:
Mean · Log10 IU/mL
Mean Log Change From Baseline in HCV RNA
Log10 IU/mLPlacebo + Peg-IFN/RibavirinVaniprevir 300 mg b.i.d. + Peg-IFN/RibavirinVaniprevir 600 mg b.i.d. + Peg-IFN/RibavirinVaniprevir 600 mg q.d. + Peg-IFN/RibavirinVaniprevir 800 mg q.d. + Peg-IFN/Ribavirin
Mean Log Change From Baseline in HCV RNA-3.6 ± 1.3-6.1 ± 1.1-6.3 ± 0.7-6.2 ± 0.6-6.3 ± 1.4
Statistical analysis
  • Placebo + Peg-IFN/Ribavirin vs Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin · Difference in least squares (lc) means: -2.5 · 95% CI -3.2 to -1.8The difference in LS Means reflects the mean decrease from baseline in HCV RNA between vaniprevir and placebo at Week 4.
  • Placebo + Peg-IFN/Ribavirin vs Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin · Difference in ls means: -2.7 · 95% CI -3.4 to -2.0The difference in LS Means reflects the mean decrease from baseline in HCV RNA between vaniprevir and placebo at Week 4.
  • Placebo + Peg-IFN/Ribavirin vs Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin · Difference in ls means: -2.7 · 95% CI -3.4 to -2.0The difference in LS Means reflects the mean decrease from baseline in HCV RNA between vaniprevir and placebo at Week 4.
  • Placebo + Peg-IFN/Ribavirin vs Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin · Difference in ls means: -2.7 · 95% CI -3.3 to -2.0The difference in LS Means reflects the mean decrease from baseline in HCV RNA between vaniprevir and placebo at Week 4.

Adverse events

Collected over AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo + Peg-IFN/Ribavirin—1/19 (5.3%)19/19 (100%)
Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin—3/18 (16.7%)16/18 (88.9%)
Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin—1/20 (5%)20/20 (100%)
Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin—2/18 (11.1%)17/18 (94.4%)
Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin—2/19 (10.5%)18/19 (94.7%)
Most frequent serious events
Most frequent serious events
EventPlacebo + Peg-IFN/RibavirinVaniprevir 300 mg b.i.d. + Peg-IFN/RibavirinVaniprevir 600 mg b.i.d. + Peg-IFN/RibavirinVaniprevir 600 mg q.d. + Peg-IFN/RibavirinVaniprevir 800 mg q.d. + Peg-IFN/Ribavirin
Cholecystitis acuteHepatobiliary disorders0/190/180/201/180/19
AppendicitisInfections and infestations0/191/180/200/180/19
GastroenteritisInfections and infestations0/191/180/200/180/19
Lobar pneumoniaInfections and infestations0/191/180/200/180/19
MyopathyMusculoskeletal and connective tissue disorders0/190/180/201/180/19
Haemoglobin decreasedInvestigations0/190/180/200/181/19
Colon cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/190/180/200/180/19
Confusional statePsychiatric disorders0/190/180/200/181/19
EmpyemaInfections and infestations0/190/181/200/180/19
Septic shockInfections and infestations0/190/181/200/180/19
Most frequent other events
Showing 10 of 179
Most frequent other events
EventPlacebo + Peg-IFN/RibavirinVaniprevir 300 mg b.i.d. + Peg-IFN/RibavirinVaniprevir 600 mg b.i.d. + Peg-IFN/RibavirinVaniprevir 600 mg q.d. + Peg-IFN/RibavirinVaniprevir 800 mg q.d. + Peg-IFN/Ribavirin
VomitingGastrointestinal disorders0/190/189/204/183/19
HeadacheNervous system disorders7/194/189/208/185/19
NauseaGastrointestinal disorders6/195/188/207/186/19
FatigueGeneral disorders7/193/187/204/183/19
DiarrhoeaGastrointestinal disorders4/191/187/202/186/19
Dry skinSkin and subcutaneous tissue disorders6/191/183/201/181/19
Decreased appetiteMetabolism and nutrition disorders2/194/186/202/181/19
InsomniaPsychiatric disorders2/194/184/205/182/19
Influenza like illnessGeneral disorders4/194/184/204/185/19
DyspnoeaRespiratory, thoracic and mediastinal disorders5/193/181/201/182/19

Baseline characteristics

The baseline population consists of all participants treated with study medication. One participant was randomized to the placebo group but withdrew from the study prior to taking any study medication.

Age, Continuous
Age, Continuous(Years)Placebo + Peg-IFN/RibavirinVaniprevir 300 mg b.i.d. + Peg-IFN/RibavirinVaniprevir 600 mg b.i.d. + Peg-IFN/RibavirinVaniprevir 600 mg q.d. + Peg-IFN/RibavirinVaniprevir 800 mg q.d. + Peg-IFN/RibavirinTotal
Mean47.8 ± 10.146.7 ± 10.242.0 ± 10.750.1 ± 8.445.1 ± 12.046.2 ± 10.5
Sex: Female, Male
Sex: Female, Male(Participants)Placebo + Peg-IFN/RibavirinVaniprevir 300 mg b.i.d. + Peg-IFN/RibavirinVaniprevir 600 mg b.i.d. + Peg-IFN/RibavirinVaniprevir 600 mg q.d. + Peg-IFN/RibavirinVaniprevir 800 mg q.d. + Peg-IFN/RibavirinTotal
Female84911739
Male11141171255
08

Study locations

No study locations are listed for this record.

09

References and documents

Publications

  • Manns MP, Gane E, Rodriguez-Torres M, Stoehr A, Yeh CT, Marcellin P, Wiedmann RT, Hwang PM, Caro L, Barnard RJ, Lee AW; MK-7009 Protocol 007 Study Group. Vaniprevir with pegylated interferon alpha-2a and ribavirin in treatment-naive patients with chronic hepatitis C: a randomized phase II study. Hepatology. 2012 Sep;56(3):884-93. doi: 10.1002/hep.25743. Epub 2012 Jul 17. PubMed 22473713 ↗
  • Lawitz E, Sulkowski M, Jacobson I, Kraft WK, Maliakkal B, Al-Ibrahim M, Gordon SC, Kwo P, Rockstroh JK, Panorchan P, Miller M, Caro L, Barnard R, Hwang PM, Gress J, Quirk E, Mobashery N. Characterization of vaniprevir, a hepatitis C virus NS3/4A protease inhibitor, in patients with HCV genotype 1 infection: safety, antiviral activity, resistance, and pharmacokinetics. Antiviral Res. 2013 Sep;99(3):214-20. doi: 10.1016/j.antiviral.2013.05.015. Epub 2013 Jun 7. PubMed 23747481 ↗

Individual participant data

Plan to share: Yes — https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 9, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00704184
Lead sponsor
Merck Sharp & Dohme LLC
Responsible party
Sponsor
First posted
Jun 24, 2008
Start date
Jul 25, 2008
Primary completion
Dec 12, 2008
Completion
Apr 14, 2010
Results posted
Oct 1, 2014
Last update
Oct 9, 2018

Study contacts

Medical Director
study director · Merck Sharp & Dohme LLC

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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