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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-002772-13 | EudraCT Number |
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This study is being done to find out if the addition of boceprevir to standard of care (SOC) treatment with peginterferon alfa-2b (PegIFN-2b) + ribavirin (RBV) is effective for participants with chronic hepatitis C (CHC) genotype 1 and cirrhosis who were not successfully treated by previous SOC. All participants will receive treatment with SOC alone for 4 weeks and then boceprevir will be added to the treatment regimen for 44 additional weeks of combined treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PegIFN-2b + RBV+ boceprevir | Experimental | Participants will receive PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) for 4 weeks and then will receive 44 additional weeks of treatment with PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) + boceprevir (capsules, orally, 800 mg three times per day). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| boceprevir | Drug |
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| PegIFN-2b |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieve Sustained Virological Response at Follow-up Week 24 (SVR24) | Hepatitis C Virus (HCV) ribonucleic acid (RNA) was measured using a polymerase chain reaction assay. SVR24 was defined as HCV RNA less than the Limit of Quantification (<25 International Units (IU)/mL) 24 weeks after the end of the Treatment Period. | Week 72 (24 weeks after end of treatment) |
| Percentage of Participants With One or More Adverse Events | Adverse events were monitored during the Lead-in and Treatment Periods | Up to 48 weeks (Lead-in and Treatment Periods) |
| Percentage of Participants With an Adverse Event Leading to Discontinuation of Study Medication | Adverse events were monitored during the Lead-in and Treatment Periods | Up to 48 weeks (Lead-in and Treatment Periods) |
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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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A total of 130 participants were screened. Sixty participants passed screening, but 2 of these participants were excluded before assignment because standard of care treatment was not received during the Lead-in Period.
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| ID | Title | Description |
|---|---|---|
| FG000 | Overall Participants | Participants received PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) for 4 weeks during the Lead-in Period and then 44 additional weeks of treatment in the Treatment Period receiving PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) + boceprevir (capsules, orally, 800 mg three times per day). After completion of treatment, follow-up continued for an additional 24 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Lead-in: Day 0 to Week 4 |
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| Biological |
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| RBV | Drug |
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| COMPLETED |
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| NOT COMPLETED |
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| Treatment / Follow-up: Week 4 to Week 72 |
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All participants who received PegIFN-2b + RBV during the Lead-in Period
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Participants | Participants received PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) for 4 weeks during the Lead-in Period and then 44 additional weeks of treatment in the Treatment Period receiving PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) + boceprevir (capsules, orally, 800 mg three times per day). After completion of treatment, follow-up continued for an additional 24 weeks. |
| 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 | Percentage of Participants Who Achieve Sustained Virological Response at Follow-up Week 24 (SVR24) | Hepatitis C Virus (HCV) ribonucleic acid (RNA) was measured using a polymerase chain reaction assay. SVR24 was defined as HCV RNA less than the Limit of Quantification (<25 International Units (IU)/mL) 24 weeks after the end of the Treatment Period. | The Intent to Treat population included all participants who received at least 1 administration of boceprevir during the Treatment Period. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 72 (24 weeks after end of treatment) |
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| Primary | Percentage of Participants With One or More Adverse Events | Adverse events were monitored during the Lead-in and Treatment Periods | Safety Analysis Set 2 included all participants who received boceprevir during the Treatment Period | Posted | Number | Percentage of participants | Up to 48 weeks (Lead-in and Treatment Periods) |
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| Primary | Percentage of Participants With an Adverse Event Leading to Discontinuation of Study Medication | Adverse events were monitored during the Lead-in and Treatment Periods | Safety Analysis Set 2 included all participants who received boceprevir during the Treatment Period | Posted | Number | Percentage of participants | Up to 48 weeks (Lead-in and Treatment Periods) |
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Up to 72 weeks (including Lead-in, Treatment, and Follow-up Periods)
Safety Analysis Set 1 included all participants who received PegIFN-2b + RBV during the Lead-in Period
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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 | Overall Participants: Lead-in, Treatment and Follow-up | Participants received PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) for 4 weeks during the Lead-in Period and then 44 additional weeks of treatment in the Treatment Period receiving PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) + boceprevir (capsules, orally, 800 mg three times per day). After completion of treatment, follow-up continued for an additional 24 weeks. | 10 | 58 | 56 | 58 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA version 17.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA version 17.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA version 17.1 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA version 17.1 | Systematic Assessment |
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| Chest pain | General disorders | MedDRA version 17.1 | Systematic Assessment |
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| Hyperpyrexia | General disorders | MedDRA version 17.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA version 17.1 | Systematic Assessment |
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| Parathyroid fever | Infections and infestations | MedDRA version 17.1 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA version 17.1 | Systematic Assessment |
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| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Systematic Assessment |
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| Hepatocellular carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 17.1 | Systematic Assessment |
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| Encephalopathy | Nervous system disorders | MedDRA version 17.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA version 17.1 | Systematic Assessment |
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| Confusional state | Psychiatric disorders | MedDRA version 17.1 | Systematic Assessment |
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| Renal impairment | Renal and urinary disorders | MedDRA version 17.1 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 17.1 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA version 17.1 | Systematic Assessment |
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| Peripheral artery stenosis | Vascular disorders | MedDRA version 17.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 17.1 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 17.1 | Systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | MedDRA version 17.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA version 17.1 | Systematic Assessment |
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| Adverse drug reaction | General disorders | MedDRA version 17.1 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA version 17.1 | Systematic Assessment |
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| Influenza like illness | General disorders | MedDRA version 17.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA version 17.1 | Systematic Assessment |
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| Accidental overdose | Injury, poisoning and procedural complications | MedDRA version 17.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA version 17.1 | Systematic Assessment |
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| Leukopenia | Blood and lymphatic system disorders | MedDRA version 17.1 | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA version 17.1 | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA version 17.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA version 17.1 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA version 17.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA version 17.1 | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA version 17.1 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA version 17.1 | Systematic Assessment |
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| Irritability | Psychiatric disorders | MedDRA version 17.1 | Systematic Assessment |
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| Nocturia | Renal and urinary disorders | MedDRA version 17.1 | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA version 17.1 | Systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | MedDRA version 17.1 | Systematic Assessment |
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| Pruritus generalized | Skin and subcutaneous tissue disorders | MedDRA version 17.1 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA version 17.1 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA version 17.1 | Systematic Assessment |
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| Hypothyroidism | Endocrine disorders | MedDRA version 17.1 | Systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA version 17.1 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA version 17.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA version 17.1 | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA version 17.1 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA version 17.1 | Systematic Assessment |
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| Pollakiuria | Renal and urinary disorders | MedDRA version 17.1 | Systematic Assessment |
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| Lacrimation increased | Eye disorders | MedDRA version 17.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA version 17.1 | Systematic Assessment |
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The investigator agrees to provide to the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the trial. The sponsor shall have the right to review and comment with respect to publications, abstracts, slides, and manuscripts and the right to review and comment on the data analysis and presentation.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C512204 | N-(3-amino-1-(cyclobutylmethyl)-2,3-dioxopropyl)-3-(2-((((1,1-dimethylethyl)amino)carbonyl)amino)-3,3-dimethyl-1-oxobutyl)-6,6-dimethyl-3-azabicyclo(3.1.0)hexan-2-carboxamide |
| C417083 | peginterferon alfa-2b |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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| Lack of Efficacy |
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| No boceprevir during Treatment Period |
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