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| ID | Type | Description | Link |
|---|---|---|---|
| VX-950HCP4010 | Other Grant/Funding Number | Janssen |
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| Name | Class |
|---|---|
| Janssen-Cilag Ltd. | INDUSTRY |
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To examine the safety and efficacy of response guided triple therapy (PEG-IFN, Ribavirin, Telaprevir) for the treatment of early chronic Hepatitis C Virus (HCV) infection.
DARE-C is a prospective open label multi-centre pilot study examining the safety and efficacy of response guided triple therapy (PEG-IFN, Ribavirin and Telaprevir) for the treatment of early chronic HCV genotype 1 infection in individuals with and without HIV infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A - 8 weeks total therapy | Experimental | 8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy |
|
| Group B - 12 weeks total therapy | Experimental | 12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy |
|
| Group C - 24 weeks total therapy | Experimental | 24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TPV/PEG-IFN/RBV | Drug | Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily. Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg). Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly. |
| Measure | Description | Time Frame |
|---|---|---|
| SVR12 (Sustain Virological Response, HCV RNA Undetectable 12 Weeks Post-treatment) | Proportion of subjects achieving SVR 12 (negative qualitative HCV RNA 12 weeks after therapy completion) | 12 weeks post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| SVR24 | To evaluate the proportion of patients with undetectable HCV RNA 24 weeks after therapy completion (SVR24) | 24 weeks post-treatment |
| Undetectable HCV RNA (ETR) | To evaluate the proportion of patients with undetectable HCV RNA at end of treatment (ETR) |
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Inclusion Criteria:
Additional inclusion criteria for HIV positive individuals
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gail Matthews, MbChB, PhD | Kirby Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Vincent's Hospital | Sydney | New South Wales | 2010 | Australia | ||
| Royal Adelaide Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26867206 | Derived | Martinello M, Hellard M, Shaw D, Petoumenos K, Applegate T, Grebely J, Yeung B, Maire L, Iser D, Lloyd A, Thompson A, Sasadeusz J, Haber P, Dore GJ, Matthews GV. Short duration response-guided treatment is effective for most individuals with recent hepatitis C infection: the ATAHC II and DARE-C I studies. Antivir Ther. 2016;21(5):425-34. doi: 10.3851/IMP3035. Epub 2016 Feb 11. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A - 8 Weeks Total Therapy | 8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily. Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg). Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly. |
| FG001 | Group B - 12 Weeks Total Therapy | 12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily. Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg). Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly. |
| FG002 | Group C - 24 Weeks Total Therapy | 24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily. Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg). Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly. |
| FG003 | No Group Allocated | Early treatment discontinuation or non-responder (participants in whom therapy was terminated at week 4 due to HCV RNA >1000 IU/mL or week 8 due to detectable HCV RNA) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group A - 8 Weeks Total Therapy | 8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily. Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg). Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | SVR12 (Sustain Virological Response, HCV RNA Undetectable 12 Weeks Post-treatment) | Proportion of subjects achieving SVR 12 (negative qualitative HCV RNA 12 weeks after therapy completion) | Posted | Number | percentage of participants | 12 weeks post-treatment |
|
Adverse events encountered during treatment and for 24 weeks after treatment discontinuation were reported for each participant.
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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 | Group A - 8 Weeks Total Therapy | 8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily. Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg). Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| A/Prof Gail Matthews | Kirby Institute | +61 (0)2 9385 0900 | gmatthews@kirby.unsw.edu.au |
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| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| D006526 | Hepatitis C |
| D006505 | Hepatitis |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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|
|
| Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C) |
| Undetectable HCV RNA (Week 1) | To evaluate the proportion of patients with undetectable HCV RNA at week 1 of therapy. | Week 1 of therapy |
| Undectectable HCV RNA (Week 2) | To evaluate the proportion of patients with undetectable HCV RNA at week 1 of therapy. | Week 2 of therapy |
| Undetectable HCV RNA (Week 3) | To evaluate the proportion of patients with undetectable HCV RNA at week 3 of therapy. | Week 3 of therapy |
| Undetectable HCV RNA (Week 4) | To evaluate the proportion of patients with undetectable HCV RNA at week 4 of therapy. | Week 4 of therapy |
| Decrease in Absolute Neutrophil Count (ANC) ≤0.75 | Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C) |
| Decrease in Platelets <50 | Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C) |
| Change in Hemoglobin at End of Treatment | To evaluate indicators of toxicity during telaprevir based therapy | Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C) |
| Resistance-associated Variants | To examine the emergence of resistance-associated variants during telaprevir based therapy for early chronic infection | Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C) |
| Baseline Resistance-associated Variants | To correlate the presence and frequency of baseline resistance-associated variants (RAVs) with the response of Telaprevir based therapy for early chronic HCV infection. | Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C) |
| Plasma Ribavirin Levels | To correlate plasma ribavirin levels with treatment outcome and changes in haemoglobin during therapy | Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C) |
| CD4 and HIV RNA | In HIV positive participants to evaluate changes in CD4 counts and HIV RNA during telaprevir based therapy | Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C) |
| Gene IL28B Polymorphism | To examine treatment outcome by IL28B polymorphism | Baseline |
| Adelaide |
| South Australia |
| 5000 |
| Australia |
| BG001 | Group B - 12 Weeks Total Therapy | 12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily. Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg). Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly. |
| BG002 | Group C - 24 Weeks Total Therapy | 24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily. Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg). Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly. |
| BG003 | No Group Allocated | Early treatment discontinuation or non-responder |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Estimated Duration of infection at baseline | Median | Inter-Quartile Range | weeks |
|
| HIV infection | Number | participants |
|
| OG001 | Group B - 12 Weeks Total Therapy | 12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily. Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg). Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly. |
| OG002 | Group C - 24 Weeks Total Therapy | 24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily. Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg). Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly. |
|
|
| Secondary | SVR24 | To evaluate the proportion of patients with undetectable HCV RNA 24 weeks after therapy completion (SVR24) | Posted | Number | percentage of participants | 24 weeks post-treatment |
|
|
|
| Secondary | Undetectable HCV RNA (ETR) | To evaluate the proportion of patients with undetectable HCV RNA at end of treatment (ETR) | Posted | Number | percentage of participants | Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C) |
|
|
|
| Secondary | Undetectable HCV RNA (Week 1) | To evaluate the proportion of patients with undetectable HCV RNA at week 1 of therapy. | Posted | Number | percentage of participants | Week 1 of therapy |
|
|
|
| Secondary | Undectectable HCV RNA (Week 2) | To evaluate the proportion of patients with undetectable HCV RNA at week 1 of therapy. | Posted | Number | percentage of participants | Week 2 of therapy |
|
|
|
| Secondary | Undetectable HCV RNA (Week 3) | To evaluate the proportion of patients with undetectable HCV RNA at week 3 of therapy. | Missing data carried forward if previously \ | Posted | Number | percentage of participants | Week 3 of therapy |
|
|
|
| Secondary | Undetectable HCV RNA (Week 4) | To evaluate the proportion of patients with undetectable HCV RNA at week 4 of therapy. | Missing data carried forward if previously \ | Posted | Number | percentage of participants | Week 4 of therapy |
|
|
|
| Secondary | Decrease in Absolute Neutrophil Count (ANC) ≤0.75 | Posted | Number | participants | Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C) |
|
|
|
| Secondary | Decrease in Platelets <50 | Posted | Number | participants | Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C) |
|
|
|
| Secondary | Change in Hemoglobin at End of Treatment | To evaluate indicators of toxicity during telaprevir based therapy | Posted | Median | Inter-Quartile Range | g/L | Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C) |
|
|
|
| Secondary | Resistance-associated Variants | To examine the emergence of resistance-associated variants during telaprevir based therapy for early chronic infection | Resistance-associated variants analysis have not yet been performed. These are planned to be performed at a later date. | Posted | Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C) |
|
|
| Secondary | Baseline Resistance-associated Variants | To correlate the presence and frequency of baseline resistance-associated variants (RAVs) with the response of Telaprevir based therapy for early chronic HCV infection. | Baseline resistance-associated variants analysis have not yet been performed. These are planned to be performed at a later date. | Posted | Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C) |
|
|
| Secondary | Plasma Ribavirin Levels | To correlate plasma ribavirin levels with treatment outcome and changes in haemoglobin during therapy | Ribavirin concentration have not yet been performed. These are planned to be performed at a later date. | Posted | Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C) |
|
|
| Secondary | CD4 and HIV RNA | In HIV positive participants to evaluate changes in CD4 counts and HIV RNA during telaprevir based therapy | This data will not be analysed. | Posted | Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C) |
|
|
| Secondary | Gene IL28B Polymorphism | To examine treatment outcome by IL28B polymorphism | IL28B polymorphisms have not yet been performed. These are planned to be performed at a later date. | Posted | Baseline |
|
|
| 2 |
| 7 |
| 7 |
| 7 |
| EG001 | Group B - 12 Weeks Total Therapy | 12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily. Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg). Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly. | 1 | 3 | 3 | 3 |
| EG002 | Group C - 24 Weeks Total Therapy | 24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily. Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg). Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly. | 0 | 2 | 2 | 2 |
| Axillary Abscess | Infections and infestations | Non-systematic Assessment |
|
| Appendicitis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Change in mood | Psychiatric disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| Injection site reaction | General disorders | Non-systematic Assessment |
|
| Perianal pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| Irritability | General disorders | Non-systematic Assessment |
|
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| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |