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Randomized trial of Hepatitis C-genotype 1-infected patients with compensated cirrhosis comparing the standard of care (Peginterferon/Ribavirin/Sofosbuvir) versus the off-label combination of simeprevir+ sofosbuvir without Ribavirin.
Patients can be treatment naive or prior null response to Peg/RBV, and must be genotype subtype 1a.
Must have Child's Class A cirrhosis/compensated and no history of decompensation
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard | Active Comparator | Pegylated Interferon Alfa-2b (1.5 ugm/kg/week subcutaneously) plus ribavirin (1000-1200 mg daily orally) plus sofosbuvir (400 mg daily) for 12 weeks |
|
| Simeprevir + Sofosbuvir | Experimental | (SIM-SOF) which is Simeprevir + Sofosbuvir for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pegylated Interferon alfa-2b | Drug | 1.5 ugm/kg/week subcutaneously injected along with ribavirin and sofosbuvir for 12 weeks total |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants With Sustained Virologic Response 12 (SVR-12) | Undetectable virus (sensitive nucleic acid test) in Serum at 3 months post-therapy | 12 weeks post-therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Serum HCV RNA Level | 4 and 12 weeks into therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian L Pearlman, MD | Center for Hepatitis C | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Hepatitis C | Atlanta | Georgia | 30309 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25557952 | Result | Pearlman BL, Ehleben C, Perrys M. The combination of simeprevir and sofosbuvir is more effective than that of peginterferon, ribavirin, and sofosbuvir for patients with hepatitis C-related Child's class A cirrhosis. Gastroenterology. 2015 Apr;148(4):762-70.e2; quiz e11-2. doi: 10.1053/j.gastro.2014.12.027. Epub 2014 Dec 31. |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Oral Therapy | Simeprevir-sofosbuvir |
| FG001 | Interferon-containing Arm | Peginterferon/ribavirin/sofosbuvir |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All participants that received at least a single dose of medication
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| ID | Title | Description |
|---|---|---|
| BG000 | Oral Therapy Arm | |
| BG001 | Interferon-containing Arm | |
| BG002 | Total |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Proportion of Participants With Sustained Virologic Response 12 (SVR-12) | Undetectable virus (sensitive nucleic acid test) in Serum at 3 months post-therapy | All participants that received at least a single dose of medication | Posted | Number | participants | 12 weeks post-therapy |
|
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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 | All Oral |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| liver decompensation | Hepatobiliary disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Brian Pearlman | Center for Hepatitis C | 4042651044 | brianpearlman3@hotmail.com |
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| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C417083 | peginterferon alfa-2b |
| D000069616 | Simeprevir |
| D012254 | Ribavirin |
| D000069474 | Sofosbuvir |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Simeprevir | Drug | 150 mg daily orally along with pegylated interferon and sofosbuvir for a total of 12 weeks |
|
|
| Ribavirin | Drug | 1000-1200 mg daily divided twice daily for 12 weeks in combination with pegylated interferon and sofosbuvir |
|
|
| Sofosbuvir | Drug | 12 weeks of combination sofosbuvir and simeprevir |
|
|
Total of all reporting groups
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
| Secondary | Serum HCV RNA Level | All participants that received at least a single dose of medication | Posted | Median | Full Range | IU/ml | 4 and 12 weeks into therapy |
|
|
|
| 0 |
| 58 |
| 46 |
| 58 |
| EG001 | Interferon-containing | 1 | 24 | 22 | 24 |
| pruritus | Skin and subcutaneous tissue disorders |
|
| insomnia | Nervous system disorders |
|
| nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| fatigue | General disorders | Non-systematic Assessment |
|
| headache | Nervous system disorders |
|
| asthenia | Gastrointestinal disorders |
|
| back pain | Musculoskeletal and connective tissue disorders |
|
| fever | General disorders |
|
| flu like illness | General disorders |
|
| myalgia | Musculoskeletal and connective tissue disorders |
|
| diarrhea | Gastrointestinal disorders |
|
| irritability | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
| neutropenia (500-750/mm3) | Blood and lymphatic system disorders |
|
| anemia | Blood and lymphatic system disorders |
|
| thrombocytopenia | Blood and lymphatic system disorders |
|
| high bilirubin | Hepatobiliary disorders |
|
| high amylase | Gastrointestinal disorders |
|
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| 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 |
| D006575 |
| Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D014542 | Uridine Monophosphate |
| D014500 | Uracil Nucleotides |
| D011742 | Pyrimidine Nucleotides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D009711 | Nucleotides |
| D012265 | Ribonucleotides |