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This randomized, parallel arm study will evaluate the efficacy and safety of Pegasys (peginterferon alfa-2a) in combination with 2 different doses of ribavirin in patients with chronic hepatitis C, genotype 2 or 3. Patients will be randomized to 4 treatment groups receiving Pegasys (180 mcg subcutaneously weekly) for either 16 or 24 weeks with one of two doses of ribavirin (400 mg or 800 mg orally daily). The anticipated time on study treatment is 16 or 24 weeks with a 24-week follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Experimental | Participants received peginterferon alfa-2a (PEG-IFNα-2a) 180 mcg once weekly + Ribavirin 800 mg daily for 24 weeks (W). |
|
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Experimental | Participants received PEG-IFNα-2a 180 mcg once weekly + Ribavirin 400 mg daily for 24 W. |
|
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Experimental | Participants received PEG-IFNα-2a 180 mcg once weekly + Ribavirin 800 mg daily for 16 W. |
|
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Experimental | Participants received PEG-IFNα-2a 180 mcg once weekly + Ribavirin 400 mg daily for 16 W. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| peginterferon alfa-2a [Pegasys] | Drug | 180 mcg sc weekly, 24 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieve Sustained Virologic Response Rate At 24 Weeks Post Completion of the Treatment | Sustained virological response was defined as the percentage of participants in each group with undetectable Hepatitis C virus-Ribonucleic acid (HCV-RNA) measurement at 24 weeks post completion of the treatment. | Up to Week 48 (24 weeks post completion of the treatment) |
| Percentage of Participants With Hepatitis C Virus-RNA Determined by AMPLICOR HCV Test At Week 24 and Week 48 | Serum Hepatitis C Virus-RNA (HCV-RNA) was done by Polymerase chain reaction (PCR). Samples for a qualitative PCR (AMPLICOR® HCV Test v2.0) were obtained at Week 24 and Week 48. 'G2' and 'G3' indicates Genotype 2 and Genotype 3 respectively. | At Week 24 and Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Virological Response at the End of the Treatment | Virological response at the end of the treatment (ETR) was defined as the percentage of participants with negative qualitative PCR in each group at completion of the treatment. ETR is defined as Week 16 and Week 24. | At Week 16 and Week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gratwein | 8112 | Austria | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21714878 | Derived | Maieron A, Metz-Gercek S, Scherzer TM, Laferl H, Fischer G, Bischof M, Gschwantler M, Ferenci P. Shortening of treatment duration in patients with chronic hepatitis C genotype 2 and 3 - impact of ribavirin dose - a randomized multicentre trial. BMC Res Notes. 2011 Jun 29;4:220. doi: 10.1186/1756-0500-4-220. |
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Of the 395 participants, 380 were randomized to treatment groups. A total of 15 participants were screening failures.
A total of 395 participants were recruited at 20 centres in Austria in the study conducted from 20 May 2003 to 10 July 2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | Peginterferon/Ribavirin 800 mg (24 Weeks) | Eligible participants were administered peginterferon alfa-2a (PEG-IFNα-2a) 180 microgram (mcg) subcutaneously (SC) once weekly + Ribavirin 800 milligram (mg) orally daily for 24 weeks (W). The untreated Follow-up was for 24 W. |
| FG001 | Peginterferon/Ribavirin 400 mg (24 Weeks) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| peginterferon alfa-2a [Pegasys] | Drug | 180 mcg sc weekly, 16 weeks |
|
| ribavirin | Drug | 800 mg orally daily |
|
| ribavirin | Drug | 400 mg orally daily |
|
| Percentage of Participants With Virologic Response Rates as Per Genotype at End of Treatment |
Virologic Response was defined as undetectable HCV-RNA levels (determined by AMPLICOR HCV test) at Week 16 and Week 24. Virologic response rates based on genotype (G2 and G3) were reported. ETR is defined as Week 16 and Week 24. |
| At Week 16 and Week 24 |
| Number of Participants With Any Adverse Events and Any Serious Adverse Events | An adverse event (AE) was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A Serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. | Up to Week 48 |
| Median Hemoglobin Levels at End of Treatment | Hemoglobin (Hb) levels at end of treatment (Week 16 and Week 24) were reported. The mean lowest Hb value after treatment starts with a median of 129 gram (g)/Litre (L). The far most frequent hemoglobin class was >=100 g/L. The purpose of assessing the Hb levels is associated with ribavirin dose. The primary toxicity of ribavirin dose (1000-1200 mg/day, maximum tolerated dose) is anemia with a reduction in hemoglobin levels generally occurring within the first 1-2 weeks of initiating therapy. Decreases in hemoglobin seen in the combination treatment of ribavirin and Interferon-alfa are managed with reduction in ribavirin dosage to 600 mg/day. | At Week 16 and Week 24 |
| Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | Short-Form Health Survey (SF-36) is a 36-item questionnaire measuring eight domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Each domain score ranges from 0 (worst) to 100 (best), with higher scores reflecting better health-related functional status. Where Baseline (BS) is Week 0. | At Baseline (Week 0) and Weeks 16, 24 and 48 |
| Mean FSS Scores at Baseline and Weeks 16, 24 and 48 | The Fatigue Severity Scale (FSS) is a self-administered instrument that includes 9 items rated on a 7-point scale, measuring fatigue severity. The participants were asked to score each statement, based on how the statement applied to them over the preceding week. The fatigue severity score is the average of the scores on the 9 questions; scores range from 1-7, with lower scores indicating less fatigue. Baseline is defined as Week 0. | At Baseline (Week 0) and Weeks 16, 24 and 48 |
| Mean Beschwerdeliste Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 16, 24 and 48 | Psychiatric assessment were performed using Beschwerdeliste (BL) questionnaires. BL results were analyzed descriptively by visit, treatment group, genotype and opioid maintenance therapy status. The BL questionnaire items were scored by calculating the average response to all answered items. Items were graded 1="stark" (affliction is strong) to 4="gar nicht" (not present). The higher the BL score, the less afflictions were present for a participant. Baseline is defined as Week 0. | At Baseline (Week 0) and Weeks 16, 24 and 48 |
| Beck Depression Inventory Mean Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 4, 8, 12, 24 and 48 | For the psychiatric assessment, the results of the Beck Depression Inventory (BDI) questionnaires were evaluated. BDI results were analyzed descriptively by visit, treatment group, genotype and opioid maintenance therapy status. BDI is 21 item participant rated inventory evaluates depression symptoms, cognition, and physical symptoms of fatigue, weight loss, lack of interest in sex. Individual items are scored on a 4 point scale (0 to 3), with 0=none/absent and 3=most severe. Total score: 0 to 63; higher score indicates more depression. Mean scores are presented by visit. Baseline is defined as Week 0. | At Baseline (Week 0) and Weeks 4, 8, 12, 24 and 48 |
| Time to Viral Response | Time to viral response was calculated as Date of first negative PCR result after screening - date of PCR screening sample + 1 [in days]. Mean of number of days to viral response for overall population were reported. | Up to Week 48 |
| Graz |
| 8036 |
| Austria |
| Innsbruck | 6020 | Austria |
| Linz | 4010 | Austria |
| Linz | 4020 | Austria |
| Oberndorf | 5110 | Austria |
| Ried-innkreis | 4910 | Austria |
| Salzburg | 5020 | Austria |
| Vienna | 1030 | Austria |
| Vienna | 1090 | Austria |
| Vienna | 1100 | Austria |
| Vienna | 1130 | Austria |
| Vienna | 1140 | Austria |
| Vienna | 1160 | Austria |
| Vienna | 1220 | Austria |
| Villach | 9500 | Austria |
| Wels | 4600 | Austria |
| Wiener Neustadt | 2700 | Austria |
Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 24 W. The untreated Follow-up was for 24 W. |
| FG002 | Peginterferon/Ribavirin 800 mg (16 Weeks) | Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 16 W. The untreated Follow-up was for 24 W. |
| FG003 | Peginterferon/Ribavirin 400 mg (16 Weeks) | Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 16 W. The untreated Follow-up was for 24 W. |
| Safety Analysis Population |
|
| Standard Analysis Population |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Peginterferon/Ribavirin 800 mg (24 Weeks) | Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 24 W. The untreated Follow-up was for 24 W. |
| BG001 | Peginterferon/Ribavirin 400 mg (24 Weeks) | Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 24 W. The untreated Follow-up was for 24 W. |
| BG002 | Peginterferon/Ribavirin 800 mg (16 Weeks) | Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 16 W. The untreated Follow-up was for 24 W. |
| BG003 | Peginterferon/Ribavirin 400 mg (16 Weeks) | Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 16 W. The untreated Follow-up was for 24 W. |
| BG004 | 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 | Mean | Standard Deviation | 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 | Percentage of Participants Who Achieve Sustained Virologic Response Rate At 24 Weeks Post Completion of the Treatment | Sustained virological response was defined as the percentage of participants in each group with undetectable Hepatitis C virus-Ribonucleic acid (HCV-RNA) measurement at 24 weeks post completion of the treatment. | Standard analysis population includes all randomized participants. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to Week 48 (24 weeks post completion of the treatment) |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Hepatitis C Virus-RNA Determined by AMPLICOR HCV Test At Week 24 and Week 48 | Serum Hepatitis C Virus-RNA (HCV-RNA) was done by Polymerase chain reaction (PCR). Samples for a qualitative PCR (AMPLICOR® HCV Test v2.0) were obtained at Week 24 and Week 48. 'G2' and 'G3' indicates Genotype 2 and Genotype 3 respectively. | Standard analysis population includes all randomized participants. | Posted | Number | 95% Confidence Interval | Percentage of participants | At Week 24 and Week 48 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Virological Response at the End of the Treatment | Virological response at the end of the treatment (ETR) was defined as the percentage of participants with negative qualitative PCR in each group at completion of the treatment. ETR is defined as Week 16 and Week 24. | Standard analysis population includes all randomized participants. | Posted | Number | 95% Confidence Interval | Percentage of participants | At Week 16 and Week 24 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Virologic Response Rates as Per Genotype at End of Treatment | Virologic Response was defined as undetectable HCV-RNA levels (determined by AMPLICOR HCV test) at Week 16 and Week 24. Virologic response rates based on genotype (G2 and G3) were reported. ETR is defined as Week 16 and Week 24. | Standard analysis population includes all randomized participants. | Posted | Number | 95% Confidence Interval | Percentage of participants | At Week 16 and Week 24 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Any Adverse Events and Any Serious Adverse Events | An adverse event (AE) was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A Serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. | The Safety analysis population was defined to include only participants who received at least one dose of (either) study medication and had at least one post-baseline assessment. | Posted | Number | Number of Participants | Up to Week 48 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Median Hemoglobin Levels at End of Treatment | Hemoglobin (Hb) levels at end of treatment (Week 16 and Week 24) were reported. The mean lowest Hb value after treatment starts with a median of 129 gram (g)/Litre (L). The far most frequent hemoglobin class was >=100 g/L. The purpose of assessing the Hb levels is associated with ribavirin dose. The primary toxicity of ribavirin dose (1000-1200 mg/day, maximum tolerated dose) is anemia with a reduction in hemoglobin levels generally occurring within the first 1-2 weeks of initiating therapy. Decreases in hemoglobin seen in the combination treatment of ribavirin and Interferon-alfa are managed with reduction in ribavirin dosage to 600 mg/day. | The Safety analysis population was defined to include only participant who received at least one dose of (either) study medication and had at least one post-baseline safety assessment. | Posted | Median | Inter-Quartile Range | g/L | At Week 16 and Week 24 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | Short-Form Health Survey (SF-36) is a 36-item questionnaire measuring eight domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Each domain score ranges from 0 (worst) to 100 (best), with higher scores reflecting better health-related functional status. Where Baseline (BS) is Week 0. | Standard analysis population includes all randomized participants. | Posted | Mean | Standard Deviation | Score on a scale | At Baseline (Week 0) and Weeks 16, 24 and 48 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean FSS Scores at Baseline and Weeks 16, 24 and 48 | The Fatigue Severity Scale (FSS) is a self-administered instrument that includes 9 items rated on a 7-point scale, measuring fatigue severity. The participants were asked to score each statement, based on how the statement applied to them over the preceding week. The fatigue severity score is the average of the scores on the 9 questions; scores range from 1-7, with lower scores indicating less fatigue. Baseline is defined as Week 0. | Standard analysis population includes all randomized participants. | Posted | Mean | Standard Deviation | Score on a scale | At Baseline (Week 0) and Weeks 16, 24 and 48 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Beschwerdeliste Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 16, 24 and 48 | Psychiatric assessment were performed using Beschwerdeliste (BL) questionnaires. BL results were analyzed descriptively by visit, treatment group, genotype and opioid maintenance therapy status. The BL questionnaire items were scored by calculating the average response to all answered items. Items were graded 1="stark" (affliction is strong) to 4="gar nicht" (not present). The higher the BL score, the less afflictions were present for a participant. Baseline is defined as Week 0. | Standard analysis population includes all randomized participants. | Posted | Mean | Standard Deviation | Score on a scale | At Baseline (Week 0) and Weeks 16, 24 and 48 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Beck Depression Inventory Mean Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 4, 8, 12, 24 and 48 | For the psychiatric assessment, the results of the Beck Depression Inventory (BDI) questionnaires were evaluated. BDI results were analyzed descriptively by visit, treatment group, genotype and opioid maintenance therapy status. BDI is 21 item participant rated inventory evaluates depression symptoms, cognition, and physical symptoms of fatigue, weight loss, lack of interest in sex. Individual items are scored on a 4 point scale (0 to 3), with 0=none/absent and 3=most severe. Total score: 0 to 63; higher score indicates more depression. Mean scores are presented by visit. Baseline is defined as Week 0. | Standard analysis population includes all randomized participants. | Posted | Mean | Standard Deviation | Score on a scale | At Baseline (Week 0) and Weeks 4, 8, 12, 24 and 48 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Viral Response | Time to viral response was calculated as Date of first negative PCR result after screening - date of PCR screening sample + 1 [in days]. Mean of number of days to viral response for overall population were reported. | Standard analysis population includes all randomized participants. | Posted | Mean | Standard Deviation | Days | Up to Week 48 |
|
Up to Week 48
An adverse event was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ribavirin 800 mg/24W | Eligible participants were administered peginterferon alfa-2a (PEG-IFNα-2a) 180 microgram (mcg) subcutaneously (SC) once weekly + Ribavirin 800 milligram (mg) orally daily for 24 weeks (W). The untreated Follow-up was for 24 W. | 12 | 144 | 133 | 144 | ||
| EG001 | Ribavirin 400 mg/24W | Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 24 W. The untreated Follow-up was for 24 W. | 18 | 141 | 128 | 141 | ||
| EG002 | Ribavirin 800 mg/16W | Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 16 W. The untreated Follow-up was for 24 W. | 0 | 30 | 27 | 30 | ||
| EG003 | Ribavirin 400 mg/16W | Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 16 W. The untreated Follow-up was for 24 W. | 2 | 48 | 38 | 48 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Perianal abscess | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Abscess | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Bartholin's abscess | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Cellulitis of arm | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Gastrointestinal infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Pilonidal abscess | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Pneumonia fungal | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Postoperative infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Right otitis externa | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Salmonella infection nos | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Septic phlebitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Staphylococcus aureus septicemia | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Cerebellar infarction | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Cerebral oedema | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Epileptic seizure | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Ophthalmic migraine | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Seizure cerebral | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Tia | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Abdominal pain nos | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Thyroiditis | Endocrine disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Acute and transient psychotic disorder | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Dependence on opiates | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Acute kidney failure | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Lymphadenopathy hilar | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Renal anemia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Coronary disease | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Darier's disease | Congenital, familial and genetic disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Sudden deafness | Ear and labyrinth disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Anterior cruciate ligament tear | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
| |
| Opiate toxicity | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Lumbar disc herniation | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 16.0 | Systematic Assessment |
| |
| Pregnancy of partner | Social circumstances | MedDRA 16.0 | Systematic Assessment |
| |
| Breast cosmetic surgery | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Flu like symptoms | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Fever | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Flu-like symptoms | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Tiredness | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Depressed mood | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Hair loss | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Exanthema | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Seborrheic eczema | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Heartburn | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Common cold | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Cephalgia | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Appetite lost | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Hypertriglyceridemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Leucopenia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Loss of weight | Investigations | MedDRA 16.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 16.0 | Systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Roche Trial Information Hotline | F. Hoffmann-La Roche AG | +41 616878333 | global.trial_information@roche.com |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C100416 | peginterferon alfa-2a |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
Not provided
Not provided
| Male |
|
| Risk Difference (RD) |
| -3.2 |
| 2-Sided |
| 95 |
| -14.0 |
| 7.6 |
| Yes |
| Non-Inferiority or Equivalence |
The statistical analysis was applied to arms Peginterferon/Ribavirin 800 mg (24 weeks) and Peginterferon/Ribavirin 400 mg (24 weeks). |
| Risk Difference (RD) | 7.2 | 2-Sided | 95 | -4.7 | 19.1 | Yes | Non-Inferiority or Equivalence | The statistical analysis was applied to arms Peginterferon/Ribavirin 800 mg (24 weeks) and Peginterferon/Ribavirin 800 mg (16 weeks). |
| Risk Difference (RD) | -21.1 | 2-Sided | 95 | -42.2 | -0.1 | Yes | Non-Inferiority or Equivalence | The statistical analysis was applied to arms Peginterferon/Ribavirin 800 mg (24 weeks) and Peginterferon/Ribavirin 400 mg (16 weeks). |
| OG003 | Peginterferon/Ribavirin 400 mg (16 Weeks) | Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 16 W. The untreated Follow-up was for 24 W. |
|
|
| Peginterferon/Ribavirin 400 mg (16 Weeks) |
Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 16 W. The untreated Follow-up was for 24 W. |
|
|
|
| OG003 |
| Peginterferon/Ribavirin 400 mg (16 Weeks) |
Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 16 W. The untreated Follow-up was for 24 W. |
|
|
| Peginterferon/Ribavirin 800 mg (16 Weeks) |
Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 16 W. The untreated Follow-up was for 24 W. |
| OG003 | Peginterferon/Ribavirin 400 mg (16 Weeks) | Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 16 W. The untreated Follow-up was for 24 W. |
|
|
| OG002 |
| Peginterferon/Ribavirin 800 mg (16 Weeks) |
Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 16 W. The untreated Follow-up was for 24 W. |
| OG003 | Peginterferon/Ribavirin 400 mg (16 Weeks) | Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 16 W. The untreated Follow-up was for 24 W. |
|
|
| OG003 | Peginterferon/Ribavirin 400 mg (16 Weeks) | Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 16 W. The untreated Follow-up was for 24 W. |
|
|
| OG003 | Peginterferon/Ribavirin 400 mg (16 Weeks) | Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 16 W. The untreated Follow-up was for 24 W. |
|
|
Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
| OG003 | Peginterferon/Ribavirin 400 mg (16 Weeks) | Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 16 W. The untreated Follow-up was for 24 W. |
|
|
| Peginterferon/Ribavirin 800 mg (16 Weeks) |
Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 16 W. The untreated Follow-up was for 24 W. |
| OG003 | Peginterferon/Ribavirin 400 mg (16 Weeks) | Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 16 W. The untreated Follow-up was for 24 W. |
|
|
Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 16 W. The untreated Follow-up was for 24 W. |
|
|
|