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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-003299-36 | EudraCT Number |
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Preliminary results of MK-5172 PN003 (NCT01353911) suggested a possible dose relationship to elevated transaminase levels in treatment with grazoprevir.
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This study will evaluate the safety, tolerability, and antiviral activity of grazoprevir (MK-5172) when administered concomitantly with peg-interferon alfa-2b (Peg-IFN) and ribavirin (RBV) to treatment-naïve participants with chronic genotype 2 (GT2) or genotype 3 (GT3) hepatitis C virus (HCV) infections.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Grazoprevir 200 mg + Peg-IFN + RBV | Experimental | Grazoprevir 200 mg in combination with Peg-IFN and RBV for 12 weeks. |
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| Grazoprevir 400 mg + Peg-IFN + RBV | Experimental | Grazoprevir 400 mg in combination with Peg-IFN and RBV for 12 weeks. |
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| Placebo + Peg-IFN + RBV | Placebo Comparator | Placebo to grazoprevir in combination with Peg-IFN and RBV for 12 weeks, followed by open-label Peg-IFN and RBV for an additional 12 weeks. |
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| Grazoprevir 800 mg + Peg-IFN + RBV | Experimental | Grazoprevir 800 mg in combination with Peg-IFN and RBV for 12 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Grazoprevir | Drug | Grazoprevir 100 mg tablets once daily for 12 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Achieving Complete Early Virologic Response (cEVR) in the Grazoprevir Treatment Arms | 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. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Achievement of Undetectable HCV Ribonucleic Acid (RNA) | 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. | Baseline to Week 12 for Grazoprevir treatment arms, Week 24 for Placebo arm |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| ID | Type | URL | Comment |
|---|---|---|---|
| CSR Synopsis | View IPD |
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No participants were randomized to the Grazoprevir 800 mg + Peg-IFN + RBV arm.
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| ID | Title | Description |
|---|---|---|
| FG000 | Grazoprevir 200 mg + Peg-IFN + RBV | Grazoprevir 200 mg once daily by mouth in combination with Peg-IFN and RBV for 12 weeks. |
| FG001 | Grazoprevir 400 mg + Peg-IFN + RBV | Grazoprevir 400 mg once daily by mouth in combination with Peg-IFN and RBV for 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo to Grazoprevir | Drug | Placebo to Grazoprevir once daily for 12 weeks |
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| Peginterferon alfa-2b (Peg-IFN) | Drug | Peg-IFN weekly subcutaneous injection at 1.5 mcg/kg/week for 12 or 24 weeks |
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| Ribavirin (RBV) | Drug | Ribavirin 200 mg capsules twice daily at a dose of 600 mg to 1400 mg based on weight for 12 or 24 weeks |
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| Number of Participants Achieving Rapid Viral Response (RVR) | RVR was defined as undetectable HCV RNA at Week 4. HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay. | Week 4 |
| Number of Participants Achieving Sustained Viral Response 12 Weeks After Completion of Therapy (SVR12) | 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. | Week 24 for Grazoprevir treatment arms, Week 36 for Placebo arm |
| Number of Participants Achieving Sustained Viral Response 24 Weeks After Completion of Therapy (SVR24) | 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. | Week 36 for Grazoprevir treatment arms, Week 48 for Placebo arm |
| Number of Participants Achieving Undetectable HCV RNA at Week 12 in the Placebo Arm | HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay. | Week 12 |
| Number of Participants Achieving Complete Early Virologic Response (cEVR) at Week 24 in the Placebo Arm | 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. | Week 24 |
| FG002 | 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. |
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| NOT COMPLETED |
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Five participants were randomized as indicated in the Participant Flow Module, but only 3 participants were treated. Baseline Characteristics are presented only for treated participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Grazoprevir 400 mg + Peg-IFN + RBV | Grazoprevir 400 mg once daily by mouth in combination with Peg-IFN and RBV for 12 weeks. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Achieving Complete Early Virologic Response (cEVR) in the Grazoprevir Treatment Arms | 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. | 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. | Posted | Week 12 |
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| Secondary | Time to First Achievement of Undetectable HCV Ribonucleic Acid (RNA) | 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. | 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. | Posted | Baseline to Week 12 for Grazoprevir treatment arms, Week 24 for Placebo arm |
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| Secondary | Number of Participants Achieving Rapid Viral Response (RVR) | RVR was defined as undetectable HCV RNA at Week 4. HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay. | 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. | Posted | Week 4 |
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| Secondary | Number of Participants Achieving Sustained Viral Response 12 Weeks After Completion of Therapy (SVR12) | 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. | 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. | Posted | Week 24 for Grazoprevir treatment arms, Week 36 for Placebo arm |
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| Secondary | Number of Participants Achieving Sustained Viral Response 24 Weeks After Completion of Therapy (SVR24) | 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. | 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. | Posted | Week 36 for Grazoprevir treatment arms, Week 48 for Placebo arm |
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| Secondary | Number of Participants Achieving Undetectable HCV RNA at Week 12 in the Placebo Arm | HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay. | 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. | Posted | Week 12 |
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| Secondary | Number of Participants Achieving Complete Early Virologic Response (cEVR) at Week 24 in the Placebo Arm | 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. | 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. | Posted | Week 24 |
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Non-serious AEs were collected up to Week 26 and serious AEs (SAEs) were collected up to Week 48.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Grazoprevir 400 mg + Peg-IFN + RBV | Grazoprevir 400 mg once daily by mouth in combination with Peg-IFN and RBV for 12 weeks. | 0 | 2 | 2 | 2 | ||
| EG001 | 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. | 0 | 1 | 1 | 1 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v. 15.1 | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA v. 15.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA v. 15.1 | Systematic Assessment |
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| Chills | General disorders | MedDRA v. 15.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA v. 15.1 | Systematic Assessment |
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| Injection site reaction | General disorders | MedDRA v. 15.1 | Systematic Assessment |
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| Irritabilty | General disorders | MedDRA v. 15.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA v. 15.1 | Systematic Assessment |
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| Fungal infection | Infections and infestations | MedDRA v. 15.1 | Systematic Assessment |
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| Localised infection | Infections and infestations | MedDRA v. 15.1 | Systematic Assessment |
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| Skeletal injury | Injury, poisoning and procedural complications | MedDRA v. 15.1 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA v. 15.1 | Systematic Assessment |
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| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA v. 15.1 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v. 15.1 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v. 15.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA v. 15.1 | Systematic Assessment |
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| Restless leg syndrome | Nervous system disorders | MedDRA v. 15.1 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA v. 15.1 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA v. 15.1 | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA v. 15.1 | Systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | MedDRA v. 15.1 | Systematic Assessment |
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| Night sweats | Skin and subcutaneous tissue disorders | MedDRA v. 15.1 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v. 15.1 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA v. 15.1 | Systematic Assessment |
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| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA v. 15.1 | Systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C578009 | grazoprevir |
| C417083 | peginterferon alfa-2b |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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| Male |
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