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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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This sudy will determine whether shortening treatment for hepatitis C is feasible, safe and effective for patients who are current injection drug users or receiving opiate substitution therapy and who are responding well to treatment early on.
The study will evaluate the feasibility, safety and effectiveness of shortened treatment for hepatitis C genotypes 2/3 in current injection drug users or receiving opiate substitution therapy. Treatment will be with pegylated interferon alfa 2b (directly observed) and ribavirin for 12 weeks in those that have non-quantifiable (<15 IU/ml detected and <15 IU/ml undetected) HCV RNA or undetectable HCV RNA on qualitative assay at week 4 and 24 weeks in those that have quantifiable (≥15 IU/ml) HCV RNA or detectable HCV RNA on qualitative assay at week 4.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Treatment Duration (24 weeks) | Active Comparator | Subjects with detectable HCV RNA after four weeks of therapy will continue on PEG-IFN and ribavirin until week 24 and follow-up for an additional 24 weeks following treatment completion (48 weeks in total). |
|
| Shortened Treatment Duration (12 Weeks) | Experimental | Subjects with undetectable HCV RNA after four weeks of therapy will continue on PEG-IFN and ribavirin until week 12 and follow-up for an additional 24 weeks following treatment completion (36 weeks in total). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pegylated interferon alfa 2b | Drug | Pegylated interferon alfa 2b 1.5 mcg/kg/week to a maximum of 150 mcg/week administered subcutaneously once weekly directly observed. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Efficacy | The primary outcome measure is the number of patients with undetectable HCV RNA at 12 weeks post end of treatment (SVR12) following directly observed PEG-IFN alfa-2b in combination with self-administered ribavirin for 12 weeks in participants with non-quantifiable (<15 IU/ml detected and <15 IU/ml undetected) HCV RNA or undetectable HCV RNA on qualitative assay at week 4 of therapy and for 24 weeks in participants with quantifiable (≥15 IU/ml) HCV RNA or detectable HCV RNA on qualitative assay at week 4 of therapy. | 36 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Adherence | Evaluate the adherence (>80 of PEG-IFN, >80% of RBV, >80% of time) to directly observed PEG-IFN alfa-2b in combination with self-administered ribavirin for 12 weeks in participants with non-quantifiable HCV RNA or undetectable HCV RNA on qualitative assay at week 4 of therapy and for 24 weeks in participants with quantifiable HCV RNA or detectable HCV RNA on qualitative assay at week 4 of therapy. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gregory Dore, MBBS, PhD | University of New South Wales | Study Chair |
| Olav Dalgard, MD PhD | University Hospital, Akershus | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hunter Pharmacotherapy | Newcastle | New South Wales | 2300 | Australia | ||
| Nepean Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28610605 | Derived | Cunningham EB, Hajarizadeh B, Dalgard O, Amin J, Hellard M, Foster GR, Bruggmann P, Conway B, Backmund M, Robaeys G, Swan T, Marks PS, Quiene S, Applegate TL, Weltman M, Shaw D, Dunlop A, Bruneau J, Midgard H, Bourgeois S, Thurnheer MC, Dore GJ, Grebely J; ACTIVATE Study Group. Adherence to response-guided pegylated interferon and ribavirin for people who inject drugs with hepatitis C virus genotype 2/3 infection: the ACTIVATE study. BMC Infect Dis. 2017 Jun 13;17(1):420. doi: 10.1186/s12879-017-2517-3. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Shortened Treatment Duration (12 Weeks) | Subjects with undetectable HCV RNA after four weeks of therapy will continue on pegylated interferon alfa 2b (PEG-IFN) and ribavirin (RBV) until week 12 and follow-up for an additional 24 weeks following treatment completion (36 weeks in total). Pegylated interferon alfa 2b: Pegylated interferon alfa 2b 1.5 mcg/kg/week to a maximum of 150 mcg/week administered subcutaneously once weekly directly observed. Ribavirin: Ribavirin - 800-1400 mg daily according to weight taken orally with food, self administered in split doses. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Ribavirin | Drug | Ribavirin - 800-1400 mg daily according to weight taken orally with food, self administered in split doses. |
|
| 48 weeks |
| Treatment Response (ETR & SVR24) | Evaluate the percentage with undetectable HCV RNA at end of treatment (ETR) and 24 weeks post end of treatment (SVR24) in participants treated with PEG-IFN alfa-2b in combination with self-administered ribavirin for 12 weeks in participants with non quantifiable HCV RNA or undetectable HCV RNA at week 4 of therapy and for 24 weeks in participants with quantifiable HCV RNA or detectable HCV RNA at week 4 of therapy. | 48 weeks |
| Behavioral and Quality of Life | Evaluate changes in illicit drug use, opiate substitution therapy, depression, suicidal ideations and health-related quality of life in participants treated with PEG-IFN alfa-2b in combination with self-administered ribavirin for 12 weeks in participants with non-quantifiable HCV RNA or undetectable HCV RNA on qualitative assay at week 4 of therapy and for 24 weeks in participants with quantifiable HCV RNA or detectable HCV RNA at week 4 of therapy. | 48 weeks |
| Penrith |
| New South Wales |
| 2751 |
| Australia |
| St Vincent's Hospital | Sydney | New South Wales | 2010 | Australia |
| Royal Adelaide Hospital | Adelaide | South Australia | 5000 | Australia |
| Alfred Hospital | Melbourne | Victoria | 3004 | Australia |
| ZNA Stuivenberg / MSOC Free Clinic | Antwerp | Belgium |
| Ziekenhuis Oost Limburg / MSOC Limburg | Genk | Belgium |
| Vancouver ID Research and Care Centre Society | Vancouver | British Columbia | V6Z2C7 | Canada |
| East Toronto Hepatitis C Program | Toronto | Ontario | M4M 3P3 | Canada |
| CHUM - Centre Hospitalier de l'Universite de Montreal | Montreal | Quebec | H2X 1P1 | Canada |
| Praxiszentrum Im Tal (PIT) | Munich | 80331 | Germany |
| Oslo/Akershus University hospitals | Oslo | Lorenskog | 1478 | Norway |
| Basel Zentrum fur Suchtmedizin | Basel | 4057 | Switzerland |
| Koda Bern/Poliklinik fur Infektiologe | Bern | 3010 | Switzerland |
| ARUD, Poliklinik Zokl 1 | Zurich | CH-8005 | Switzerland |
| East London Foundation NHS Trust | London | E1 4DG | United Kingdom |
| Nottingham University Hospitals NHS Trust | Nottingham | NG5 1PB | United Kingdom |
| FG001 | Standard Treatment Duration (24 Weeks) | Subjects with detectable HCV RNA after four weeks of therapy will continue on pegylated interferon alfa 2b (PEG-IFN) and ribavirin (RBV) until week 24 and follow-up for an additional 24 weeks following treatment completion (48 weeks in total). Pegylated interferon alfa 2b: Pegylated interferon alfa 2b 1.5 mcg/kg/week to a maximum of 150 mcg/week administered subcutaneously once weekly directly observed. Ribavirin: Ribavirin - 800-1400 mg daily according to weight taken orally with food, self administered in split doses. |
| FG002 | Discontinued Prior to Week 4 | Participants who discontinued therapy prior to week 4 HCV RNA assessment and were therefore not placed in either study arms. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Treatment Duration (24 Weeks) | Subjects with detectable HCV RNA after four weeks of therapy will continue on PEG-IFN and ribavirin until week 24 and follow-up for an additional 24 weeks following treatment completion (48 weeks in total). Pegylated interferon alfa 2b: Pegylated interferon alfa 2b 1.5 mcg/kg/week to a maximum of 150 mcg/week administered subcutaneously once weekly directly observed. Ribavirin: Ribavirin - 800-1400 mg daily according to weight taken orally with food, self administered in split doses. |
| BG001 | Shortened Treatment Duration (12 Weeks) | Subjects with undetectable HCV RNA after four weeks of therapy will continue on PEG-IFN and ribavirin until week 12 and follow-up for an additional 24 weeks following treatment completion (36 weeks in total). Pegylated interferon alfa 2b: Pegylated interferon alfa 2b 1.5 mcg/kg/week to a maximum of 150 mcg/week administered subcutaneously once weekly directly observed. Ribavirin: Ribavirin - 800-1400 mg daily according to weight taken orally with food, self administered in split doses. |
| BG002 | Discontinued Prior to RVR | Participants who discontinued therapy prior to RVR assessment at week 4 and were therefore not placed in either study arms. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | Treatment Efficacy | The primary outcome measure is the number of patients with undetectable HCV RNA at 12 weeks post end of treatment (SVR12) following directly observed PEG-IFN alfa-2b in combination with self-administered ribavirin for 12 weeks in participants with non-quantifiable (<15 IU/ml detected and <15 IU/ml undetected) HCV RNA or undetectable HCV RNA on qualitative assay at week 4 of therapy and for 24 weeks in participants with quantifiable (≥15 IU/ml) HCV RNA or detectable HCV RNA on qualitative assay at week 4 of therapy. | ITT | Posted | Count of Participants | Participants | 36 weeks |
|
|
| ||||||||||||||||||||||||||||||||
| Secondary | Treatment Adherence | Evaluate the adherence (>80 of PEG-IFN, >80% of RBV, >80% of time) to directly observed PEG-IFN alfa-2b in combination with self-administered ribavirin for 12 weeks in participants with non-quantifiable HCV RNA or undetectable HCV RNA on qualitative assay at week 4 of therapy and for 24 weeks in participants with quantifiable HCV RNA or detectable HCV RNA on qualitative assay at week 4 of therapy. | Not Posted | 48 weeks | Participants | |||||||||||||||||||||||||||||||||||||
| Secondary | Treatment Response (ETR & SVR24) | Evaluate the percentage with undetectable HCV RNA at end of treatment (ETR) and 24 weeks post end of treatment (SVR24) in participants treated with PEG-IFN alfa-2b in combination with self-administered ribavirin for 12 weeks in participants with non quantifiable HCV RNA or undetectable HCV RNA at week 4 of therapy and for 24 weeks in participants with quantifiable HCV RNA or detectable HCV RNA at week 4 of therapy. | Not Posted | 48 weeks | Participants | |||||||||||||||||||||||||||||||||||||
| Secondary | Behavioral and Quality of Life | Evaluate changes in illicit drug use, opiate substitution therapy, depression, suicidal ideations and health-related quality of life in participants treated with PEG-IFN alfa-2b in combination with self-administered ribavirin for 12 weeks in participants with non-quantifiable HCV RNA or undetectable HCV RNA on qualitative assay at week 4 of therapy and for 24 weeks in participants with quantifiable HCV RNA or detectable HCV RNA at week 4 of therapy. | Not Posted | 48 weeks | Participants |
Adverse events were collected from the date of signing the consent until 24 weeks post-treatment.
Laboratory abnormalities only recorded as AEs if it caused a Serious Adverse Event (SAE), resulted in discontinuation/modification of study treatment or required treatment with, or modification to, concomitant medication. Pre-existing conditions/diseases that occurred during the study were not considered as adverse events unless they changed in frequency or severity. Participants were assessed at each study visit for adverse events.
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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 | Standard Treatment Duration (24 Weeks) | Subjects with detectable HCV RNA after four weeks of therapy will continue on PEG-IFN and ribavirin until week 24 and follow-up for an additional 24 weeks following treatment completion (48 weeks in total). Pegylated interferon alfa 2b: Pegylated interferon alfa 2b 1.5 mcg/kg/week to a maximum of 150 mcg/week administered subcutaneously once weekly directly observed. Ribavirin: Ribavirin - 800-1400 mg daily according to weight taken orally with food, self administered in split doses. | 4 | 26 | 26 | 26 | ||
| EG001 | Shortened Treatment Duration (12 Weeks) | Subjects with undetectable HCV RNA after four weeks of therapy will continue on PEG-IFN and ribavirin until week 12 and follow-up for an additional 24 weeks following treatment completion (36 weeks in total). Pegylated interferon alfa 2b: Pegylated interferon alfa 2b 1.5 mcg/kg/week to a maximum of 150 mcg/week administered subcutaneously once weekly directly observed. Ribavirin: Ribavirin - 800-1400 mg daily according to weight taken orally with food, self administered in split doses. | 6 | 61 | 60 | 61 | ||
| EG002 | Discontinued Prior to RVR | Participants who discontinued therapy prior to RVR assessment at week 4 and were therefore not placed in either study arms. | 1 | 6 | 5 | 6 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Poisoning | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Road Traffic Accident | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Abscess | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Drug dependence | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jason Grebely | Viral Hepatits Clinical Research Program - The Kirby Institute - UNSW Sydney | +61 2938 50957 | Jgrebely@kirby.unsw.edu.au |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| 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 |
| 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 |
|---|---|
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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| Male |
|