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| Name | Class |
|---|---|
| Bioikos Ambiente Srl | OTHER |
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The objective of this study is to evaluate the efficacy of three regimens of pegylated interferon-alfa 2b (PEG-IFN) either as monotherapy or in combination with ribavirin in participants with acute hepatitis C. After 12 weeks of observation from disease onset, participants will receive one of the following regimens: (1) a 24-week course of PEG-IFN monotherapy (PEG-IFN 24); or (2) a 12-week course of PEG-IFN monotherapy (PEG-IFN-12); or (3) a 12-week course of PEG-IFN in combination with ribavirin (PEG-IFN + RVB 12). After the treatment period, participants will enter a 12-month follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEG-IFN 24 | Experimental | pegylated interferon alpha-2b 1.5 ug/kg/week for 24 weeks |
|
| PEG-IFN 12 | Experimental | pegylated interferon alpha-2b 1.5 ug/kg/week for 12 weeks |
|
| PEG-IFN + RVB 12 | Experimental | pegylated interferon alpha-2b 1.5 ug/kg/week in combination with ribavirin at the dose of 10.6 mg/kg/day for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pegylated interferon alfa-2b | Biological | 1.5 ug/kg/week SC for 12 or 24 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Sustained Response (SR) at the End of the 6-month Follow-up Period | SR was defined as serum Hepatitis C Virus (HCV RNA) level at the end of 6-month follow-up below 15 IU/mL. | Evaluated at the end of 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Virologic Response at the End of Treatment Follow-up (ETR) | ETR was achieved if serum HCV RNA level at the end of 12 or 24 weeks treatment (depending on treatment arm) was <15 IU/mL. | At the end of treatment (either 12 weeks or 24 weeks depending on randomization). |
| Virologic Response at 12 Months Post-treatment Follow-up (Long-term Response, [LTR]). |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24442928 | Result | Santantonio T, Fasano M, Sagnelli E, Tundo P, Babudieri S, Fabris P, Toti M, Di Perri G, Marino N, Pizzigallo E, Angarano G; Acute Hepatitis C Study Group. Acute hepatitis C: a 24-week course of pegylated interferon alpha-2b versus a 12-week course of pegylated interferon alpha-2b alone or with ribavirin. Hepatology. 2014 Jun;59(6):2101-9. doi: 10.1002/hep.26991. Epub 2014 Apr 29. |
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130 participants were randomized to pegylated-interferon alpha-2b at the dose of 1.5 mcg/kg/week for 24 weeks (PEG-IFN 24), pegylated-interferon alpha-2b at the dose of 1.5 mcg/kg/week for 12 weeks (PEG-IFN 12), or pegylated-interferon alpha-2b at the dose of 1.5 mcg/kg/week + ribavirin at the dose of 10.6 mg/kg/day for 12 weeks (PEG-IFN + RVB 12).
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| ID | Title | Description |
|---|---|---|
| FG000 | PEG-IFN 24 | Pegylated interferon alpha-2b 1.5 ug/kg/week for 24 weeks |
| FG001 | PEG-IFN 12 | Pegylated interferon alpha-2b 1.5 ug/kg/week for 12 weeks |
| FG002 | PEG-IFN + RVB 12 | Pegylated interferon alpha-2b 1.5 ug/kg/week in combination with ribavirin 10.6 mg/kg/day for 12 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment |
|
| ||||||||||||||||||||||||
| Follow-up |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PEG-IFN 24 | Pegylated interferon alpha-2b 1.5 ug/kg/week for 24 weeks |
| BG001 | PEG-IFN 12 | Pegylated interferon alpha-2b 1.5 ug/kg/week for 12 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 With Sustained Response (SR) at the End of the 6-month Follow-up Period | SR was defined as serum Hepatitis C Virus (HCV RNA) level at the end of 6-month follow-up below 15 IU/mL. | Intent-to-treat population (ITT): including all randomized participants who received at least one dose of study medication. Participants without measurements at the end of treatment or who discontinued the study for any reason before the end of the treatment were considered as non-responders. | Posted | Number | participants | Evaluated at the end of 6 months |
|
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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 | PEG-IFN 12 | Pegylated interferon alpha-2b 1.5 ug/kg/week for 12 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| HypoAcusis | Ear and labyrinth disorders | MedDRA 12.1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA 12.1 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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| ID | Term |
|---|---|
| C417083 | peginterferon alfa-2b |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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| Ribavirin | Drug | Ribavirin at the dose of 10.6 mg/kg/day for 12 weeks |
|
|
LTR was obtained if serum HCV RNA level at the end of 12-month follow-up was <15 IU/mL. |
| At 12 months post-treatment (treatment period either 12 weeks or 24 weeks depending on randomization). |
| Number of Participants Presenting With Alanine Transferase (ALT) Level Normalization | ALT normalization was used as a measure of biochemical response to treatment. ALT levels were assessed at each study visit by the local laboratory, and efficacy measurements at the end of treatment, at 6 and 12 months post treatment follow-up were reported. | Evaluated at end of treatment (either 12 weeks or 24 weeks, depending on randomization), at 6-month follow-up visit, or at 12-month follow-up visit. |
| Number of Participants With Rapid Virologic Response (RVR) | Participants were considered to have RVR if serum HCV RNA level at 2 or 4 weeks of treatment was below the cut off value of the referring local laboratory of each participating site. | Evaluated at 2 and 4 weeks of treatment |
| Number of Peripheral Blood Mononuclear Cells (PBMCs) | Cellular Differentiation Cluster Antigen 8-Positive (CD8+) PBMCs were measured at randomization, Treatment Weeks 2, 4, 8, and 12. | Treatment Weeks 2, 4, 8, and 12 |
| Poor Protocol Compliance |
|
| Protocol Violation |
|
| NOT COMPLETED |
|
| BG002 | PEG-IFN + RVB 12 | Pegylated interferon alpha-2b 1.5 ug/kg/week in combination with ribavirin 10.6 mg/kg/day for 12 weeks |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Pegylated interferon alpha-2b 1.5 ug/kg/week for 12 weeks
| OG002 | PEG-IFN + RVB 12 | Pegylated interferon alpha-2b 1.5 ug/kg/week in combination with ribavirin 10.6 mg/kg/day for 12 weeks |
|
|
| Secondary | Virologic Response at the End of Treatment Follow-up (ETR) | ETR was achieved if serum HCV RNA level at the end of 12 or 24 weeks treatment (depending on treatment arm) was <15 IU/mL. | Intent-to-treat population (ITT): including all randomized participants who received at least one dose of study medication. Participants without measurements at the end of treatment or who discontinued the study for any reason before the end of the treatment were considered as non-responders. | Posted | Number | participants | At the end of treatment (either 12 weeks or 24 weeks depending on randomization). |
|
|
|
| Secondary | Virologic Response at 12 Months Post-treatment Follow-up (Long-term Response, [LTR]). | LTR was obtained if serum HCV RNA level at the end of 12-month follow-up was <15 IU/mL. | Intent-to-treat population (ITT): including all randomized participants who received at least one dose of study medication. Participants without measurements at the end of treatment or who discontinued the study for any reason before the end of the treatment were considered as non-responders. | Posted | Number | participants | At 12 months post-treatment (treatment period either 12 weeks or 24 weeks depending on randomization). |
|
|
|
| Secondary | Number of Participants Presenting With Alanine Transferase (ALT) Level Normalization | ALT normalization was used as a measure of biochemical response to treatment. ALT levels were assessed at each study visit by the local laboratory, and efficacy measurements at the end of treatment, at 6 and 12 months post treatment follow-up were reported. | Intent-to-treat population (ITT): including all randomized participants who received at least one dose of study medication. Participants without measurements at the end of treatment or who discontinued the study for any reason before the end of the treatment were considered as non-responders. | Posted | Number | participants | Evaluated at end of treatment (either 12 weeks or 24 weeks, depending on randomization), at 6-month follow-up visit, or at 12-month follow-up visit. |
|
|
|
| Secondary | Number of Participants With Rapid Virologic Response (RVR) | Participants were considered to have RVR if serum HCV RNA level at 2 or 4 weeks of treatment was below the cut off value of the referring local laboratory of each participating site. | Intent-to-treat population (ITT): including all randomized participants who received at least one dose of study medication. Participants without measurements at the end of treatment or who discontinued the study for any reason before the end of the treatment were considered as non-responders. | Posted | Number | participants | Evaluated at 2 and 4 weeks of treatment |
|
|
|
| Secondary | Number of Peripheral Blood Mononuclear Cells (PBMCs) | Cellular Differentiation Cluster Antigen 8-Positive (CD8+) PBMCs were measured at randomization, Treatment Weeks 2, 4, 8, and 12. | The association between HCV specific immune and SR to be assessed applying descriptive methods could not be evaluated as PBMC measurements were not carried out. | Posted | Treatment Weeks 2, 4, 8, and 12 |
|
|
| 3 |
| 43 |
| 37 |
| 43 |
| EG001 | PEG-IFN 24 | Pegylated interferon alpha-2b 1.5 ug/kg/week for 24 weeks | 4 | 44 | 43 | 44 |
| EG002 | PEG-IFN + RVB 12 | Pegylated interferon alpha-2b 1.5 ug/kg/week in combination with ribavirin 10.6 mg/kg/day for 12 weeks | 4 | 43 | 42 | 43 |
| Autoimmune thyroiditis | Endocrine disorders | MedDRA 12.1 |
|
| Diarrhea | Gastrointestinal disorders | MedDRA 12.1 |
|
| Vomiting | Gastrointestinal disorders | MedDRA 12.1 |
|
| Dacryocystitis | Infections and infestations | MedDRA 12.1 |
|
| Wound Infection | Infections and infestations | MedDRA 12.1 |
|
| Transaminases Increased | Investigations | MedDRA 12.1 |
|
| Lung Neoplasm Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 |
|
| Headache | Nervous system disorders | MedDRA 12.1 |
|
| Optic Neuritis | Nervous system disorders | MedDRA 12.1 |
|
| Mania | Psychiatric disorders | MedDRA 12.1 |
|
| Pyschotic Disorder | Psychiatric disorders | MedDRA 12.1 |
|
| Granulocytopenia | Blood and lymphatic system disorders | MedDRA 12.1 |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 12.1 |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 12.1 |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA 12.1 |
|
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA 12.1 |
|
| Constipation | Gastrointestinal disorders | MedDRA 12.1 |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 12.1 |
|
| Nausea | Gastrointestinal disorders | MedDRA 12.1 |
|
| Asthenia | General disorders | MedDRA 12.1 |
|
| Chills | General disorders | MedDRA 12.1 |
|
| Irritability | General disorders | MedDRA 12.1 |
|
| Pain | General disorders | MedDRA 12.1 |
|
| Pyrexia | General disorders | MedDRA 12.1 |
|
| Hemoglobin Decreased | Investigations | MedDRA 12.1 |
|
| Platelet Count Decreased | Investigations | MedDRA 12.1 |
|
| Transaminases Increased | Investigations | MedDRA 12.1 |
|
| Weight Decreased | Investigations | MedDRA 12.1 |
|
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA 12.1 |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 12.1 |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 12.1 |
|
| Headache | Nervous system disorders | MedDRA 12.1 |
|
| Anxiety | Psychiatric disorders | MedDRA 12.1 |
|
| Depression | Psychiatric disorders | MedDRA 12.1 |
|
| Insomia | Psychiatric disorders | MedDRA 12.1 |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 12.1 |
|
| Erythrema | Skin and subcutaneous tissue disorders | MedDRA 12.1 |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 12.1 |
|
The investigator agrees not to publish or publish or present any results of the study without the prior written permission of Schering-Plough The principal investigator further agrees to allow the Sponsor to review, 30 days prior to submission for publication or presentation, copies of abstracts or manuscripts for publication (including texts of oral presentations) which report any results of the study.
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
|
| 12-month Follow-up Period |
|
|