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Naïve patients with chronic hepatitis C (CHC) of any genotype will be treated with a standard treatment regimen (pegylated interferon and ribavirin) according to routine clinical practice in Russia. The objective of this study is to examine the influence of insulin resistance on the safety and efficacy of treatment with pegylated interferon and ribavirin and to determine the prevalence of insulin resistance in different populations of CHC patients.
consecutive patient sampling
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with chronic hepatitis C | Naïve patients with chronic hepatitis C (CHC) of any genotype will be treated with a standard treatment regimen (pegylated interferon and ribavirin) according to routine clinical practice in Russia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pegylated Interferon | Biological | Routine treatment with a combination of any pegylated interferon and ribavirin was used according to the label/local practice in Russia. The treatment course duration complied with the labeled dosage regimen. Each dose of pegylated interferon was administered as a subcutaneous injection calculated as 1.5 mcg/kg once a week. Therapy duration varied from 24 to 48 weeks depending on Hepatitis C virus (HCV) genotype, viral load, activity and stage of hepatitis C. The Sponsor did not provide formal drug supply. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved Sustained Virological Response as Assessed at End of Study | Sustained Virological response (SVR) was assessed at the end of the study (Visit 4) to investigate the presence or absence of SVR. SVR was defined as undetectable plasma hepatitis C virus RNA (HCV-RNA) at 24 weeks after termination of treatment. Visit 4 was considered Week 48 or Week 72 depending on a treatment duration of 24 or 48 weeks respectively. | 24 weeks following completion of 24 or 48 weeks of therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved Sustained Virological Response as Assessed at End of Study by HCV Genotype and Presence of Insulin-Resistance at Baseline | SVR was assessed at the end of the study (Visit 4) by HCV genotype (I, II, III, or other) and presence of insulin-resistance at baseline (defined as Homeostasis model assessment - of insulin-resistance [HOMA-IR] >3) to investigate the presence or absence of SVR. SVR was defined as undetectable plasma HCV-RNA at 24 weeks after termination of treatment. Visit 4 was considered Week 48 or Week 72 depending on a treatment duration of 24 or 48 weeks respectively. |
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Inclusion Criteria:
Exclusion Criteria:
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The study will include naïve patients with chronic hepatitis C (CHC) of any genotype who will be treated with a standard treatment regimen (pegylated interferon and ribavirin) according to routine clinical practice in Russia.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pegylated Interferon and Ribavirin | Naïve patients with chronic hepatitis C (CHC) of any genotype treated with a standard treatment regimen of pegylated interferon and ribavirin according to routine clinical practice in Russia. Each dose of pegylated interferon was administered as a subcutaneous injection calculated as 1.5 mcg/kg once a week. The doses were corrected in case adverse events related to pegylated interferon registered. Ribavirin was taken orally as 200 mg gelatinous capsules. The daily dose varied from 800 to 1200 mg (depending on patient's body weight) twice daily in the morning and in the evening with meal. Therapy duration varied from 24 to 48 weeks depending on hepatitis C virus (HCV) genotype, viral load, activity and stage of hepatitis C. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pegylated Interferon and Ribavirin | Naïve patients with CHC of any genotype treated with a standard treatment regimen of pegylated interferon and ribavirin according to routine clinical practice in Russia. Each dose of pegylated interferon was administered as a subcutaneous injection calculated as 1.5 mcg/kg once a week. The doses were corrected in case adverse events related to pegylated interferon registered. Ribavirin was taken orally as 200 mg gelatinous capsules. The daily dose varied from 800 to 1200 mg (depending on patient's body weight) twice daily in the morning and in the evening with meal. Therapy duration varied from 24 to 48 weeks depending on HCV genotype, viral load, activity and stage of hepatitis C. |
| 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 | Percentage of Participants Who Achieved Sustained Virological Response as Assessed at End of Study | Sustained Virological response (SVR) was assessed at the end of the study (Visit 4) to investigate the presence or absence of SVR. SVR was defined as undetectable plasma hepatitis C virus RNA (HCV-RNA) at 24 weeks after termination of treatment. Visit 4 was considered Week 48 or Week 72 depending on a treatment duration of 24 or 48 weeks respectively. | Completer set for the primary analysis included all participants who were administered at least one dose of the study treatment and provided the SVR data at end of study. | Posted | Number | 95% Confidence Interval | Percentage of Participants | 24 weeks following completion of 24 or 48 weeks of therapy |
|
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Safety set: All participants who were administered at least one dose of the study treatment.
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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 | Pegylated Interferon and Ribavirin | Naïve patients with chronic hepatitis C (CHC) of any genotype treated with a standard treatment regimen of pegylated interferon and ribavirin according to routine clinical practice in Russia. Each dose of pegylated interferon was administered as a subcutaneous injection calculated as 1.5 mcg/kg once a week. The doses were corrected in case adverse events related to pegylated interferon registered. Ribavirin was taken orally as 200 mg gelatinous capsules. The daily dose varied from 800 to 1200 mg (depending on patient's body weight) twice daily in the morning and in the evening with meal. Therapy duration varied from 24 to 48 weeks depending on HCV genotype, viral load, activity and stage of hepatitis C. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Drug Exposure During Pregnancy | Injury, poisoning and procedural complications | MedDRA (14.0) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (14.0) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| 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 | Routine treatment with a combination of any pegylated interferon and ribavirin was used according to the label/local practice in Russia. The treatment course duration complied with the labeled dosage regimen. Ribavirin was taken orally as 200 mg gelatinous capsules. The daily dose varied from 800 to 1200 mg (depending on patient's body weight) twice daily in the morning and in the evening with meal. Therapy duration varied from 24 to 48 weeks depending on HCV genotype, viral load, activity and stage of hepatitis C. The Sponsor did not provide formal drug supply. |
|
|
| 24 weeks following completion of 24 or 48 weeks of therapy |
| Percentage of Participants Who Achieved Response Following Treatment as Assessed at End of Treatment by HCV Genotype and Presence of Insulin-Resistance at Baseline | Response following treatment (RFT) was assessed at the end of treatment (Visit 3) by HCV genotype (I, II, III, or other) and presence of insulin-resistance at baseline (defined as HOMA-IR >3) to investigate the presence or absence of RFT. RFT was defined as undetectable plasma HCV-RNA at end of treatment. Visit 3 was considered Week 24 or Week 48 after treatment start depending on treatment duration. | Week 24 or 48 after treatment start |
| Percentage of Participants Who Demonstrated Virological Relapse as Assessed at End of Study by HCV Genotype and Presence of Insulin-Resistance at Baseline | Virological relapse (VR) was assessed at the end of the study (Visit 4) by HCV genotype (I, II, III, or other) and presence of insulin-resistance at baseline (defined as HOMA-IR >3) to investigate the percentage of participants who demonstrated VR. VR was defined as undetectable plasma HCV-RNA (RFT +) at end of treatment (Visit 3- considered Week 24 or Week 48 after treatment start depending on treatment duration), but lost RFT (considered sustained non-Responders) at end of study (Visit 4- considered Week 48 or Week 72 depending on a treatment duration of 24 or 48 weeks respectively). | 24 weeks following completion of 24 or 48 weeks of therapy |
| Percentage of Participants Who Achieved Early Virological Response as Assessed at Visit 2 by HCV Genotype and Presence of Insulin-Resistance at Baseline | Early Virological response (EVR) was assessed at 12 weeks after treatment start (Visit 2) by HCV genotype (I, II, III, or other) and presence of insulin-resistance at baseline (defined as HOMA-IR >3) to investigate the percentage of participants who achieved EVR. EVR was defined as a substantial (greater than 2 log10) decrease in viral load (measured as International Units/milliliter) and/or negative Polymerase chain reaction (PCR)-based viral load qualitative result as assessed at visit 2 of the study. | Week 12 after treatment start |
| Lost to Follow-up |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Percentage of Participants Who Achieved Sustained Virological Response as Assessed at End of Study by HCV Genotype and Presence of Insulin-Resistance at Baseline | SVR was assessed at the end of the study (Visit 4) by HCV genotype (I, II, III, or other) and presence of insulin-resistance at baseline (defined as Homeostasis model assessment - of insulin-resistance [HOMA-IR] >3) to investigate the presence or absence of SVR. SVR was defined as undetectable plasma HCV-RNA at 24 weeks after termination of treatment. Visit 4 was considered Week 48 or Week 72 depending on a treatment duration of 24 or 48 weeks respectively. | Completer set for the primary analysis (N=223) included all participants who were administered at least one dose of the study treatment and provided the SVR data at end of study. Of the 223 participants in this population, 181 achieved SVR (N=140 and N=40) and were therefore included in this analysis. 1 participant of the 181 had missing values. | Posted | Number | Percentage of Participants | 24 weeks following completion of 24 or 48 weeks of therapy |
|
|
|
| Secondary | Percentage of Participants Who Achieved Response Following Treatment as Assessed at End of Treatment by HCV Genotype and Presence of Insulin-Resistance at Baseline | Response following treatment (RFT) was assessed at the end of treatment (Visit 3) by HCV genotype (I, II, III, or other) and presence of insulin-resistance at baseline (defined as HOMA-IR >3) to investigate the presence or absence of RFT. RFT was defined as undetectable plasma HCV-RNA at end of treatment. Visit 3 was considered Week 24 or Week 48 after treatment start depending on treatment duration. | Completer set for the primary analysis (N=223) included all participants who were administered at least one dose of the study treatment and provided the SVR data at end of study. Of the 223 participants in this population, 208 achieved RFT (N=156 and N=51) and were therefore included in this analysis. 1 participant of the 208 had missing values. | Posted | Number | Percentage of Participants | Week 24 or 48 after treatment start |
|
|
|
| Secondary | Percentage of Participants Who Demonstrated Virological Relapse as Assessed at End of Study by HCV Genotype and Presence of Insulin-Resistance at Baseline | Virological relapse (VR) was assessed at the end of the study (Visit 4) by HCV genotype (I, II, III, or other) and presence of insulin-resistance at baseline (defined as HOMA-IR >3) to investigate the percentage of participants who demonstrated VR. VR was defined as undetectable plasma HCV-RNA (RFT +) at end of treatment (Visit 3- considered Week 24 or Week 48 after treatment start depending on treatment duration), but lost RFT (considered sustained non-Responders) at end of study (Visit 4- considered Week 48 or Week 72 depending on a treatment duration of 24 or 48 weeks respectively). | Completer set for the primary analysis (N=223) included all participants who were administered at least one dose of the study treatment and provided the SVR data at end of study. Of the 223 participants in this population, 29 participants demonstrated virological relapse (N=18 and N=11) and were therefore included in this analysis. | Posted | Number | Percentage of Participants | 24 weeks following completion of 24 or 48 weeks of therapy |
|
|
|
| Secondary | Percentage of Participants Who Achieved Early Virological Response as Assessed at Visit 2 by HCV Genotype and Presence of Insulin-Resistance at Baseline | Early Virological response (EVR) was assessed at 12 weeks after treatment start (Visit 2) by HCV genotype (I, II, III, or other) and presence of insulin-resistance at baseline (defined as HOMA-IR >3) to investigate the percentage of participants who achieved EVR. EVR was defined as a substantial (greater than 2 log10) decrease in viral load (measured as International Units/milliliter) and/or negative Polymerase chain reaction (PCR)-based viral load qualitative result as assessed at visit 2 of the study. | Completer set for the primary analysis (N=223) included all participants who were administered at least one dose of the study treatment and provided the SVR data at end of study. Of the 223 participants in this population, 210 participants demonstrated early virological response (N=158 and N=50). 2 participants of the 210 had missing values. | Posted | Number | Percentage of Participants | Week 12 after treatment start |
|
|
|
| 2 |
| 250 |
| 177 |
| 250 |
| Acoustic Neuritis | Nervous system disorders | MedDRA (14.0) |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA (14.0) |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (14.0) |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (14.0) |
|
| Asthenia | General disorders | MedDRA (14.0) |
|
| Influenza Like Illness | General disorders | MedDRA (14.0) |
|
| Pyrexia | General disorders | MedDRA (14.0) |
|
| Weight Decreased | Investigations | MedDRA (14.0) |
|
| Depression | Psychiatric disorders | MedDRA (14.0) |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (14.0) |
|
PI agrees for a period of five years following the Effective Date to retain the Disclosure made to the SPONSOR or on behalf of SPONSOR, in confidence and not disclose it to any third party.
| 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 |
| Genotype III |
|
| Other |
|
| Genotype III |
|
| Other |
|
| Genotype III |
|
| Other |
|
| Genotype III |
|
| Other |
|