An observational study in Hepatitis C, Chronic and Hepatitis C Virus, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2015-07-01.
Sponsored by Merck Sharp & Dohme LLC · Observational
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
2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's enrollment of 250 is close to the median of 250 across 687 observational studies indexed under Hepatitis A.
Browse Hepatitis A studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.
Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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.
Biological: Pegylated Interferon · Drug: Ribavirin
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.
Also known as: PegIntron, (SCH 54031)
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.
Also known as: Rebetol, (SCH 18908)
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.
Time frame: 24 weeks following completion of 24 or 48 weeks of therapy
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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: Week 12 after treatment start
| Milestone | Pegylated Interferon and Ribavirin |
|---|---|
| Started | 250 |
| Completed | 239 |
| Not completed | 11 |
| Withdrew: Adverse event | 1 |
| Withdrew: Lack of efficacy | 2 |
| Withdrew: Withdrawal by subject | 3 |
| Withdrew: Lost to follow-up | 5 |
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.
| Percentage of Participants | Pegylated Interferon and Ribavirin |
|---|---|
| Percentage of Participants Who Achieved Sustained Virological Response as Assessed at End of Study | 81.2 (76.0 to 86.3) |
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.
| Percentage of Participants | HOMA-IR<=3 | HOMA-IR >3 |
|---|---|---|
| Genotype I | 45.7 | 47.5 |
| Genotype II | 14.3 | 7.5 |
| Genotype III | 38.6 | 45.0 |
| Other | 1.4 | 0 |
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.
| Percentage of Participants | HOMA-IR<=3 | HOMA-IR >3 |
|---|---|---|
| Genotype I | 50.6 | 52.9 |
| Genotype II | 12.2 | 5.9 |
| Genotype III | 35.9 | 41.2 |
| Other | 1.3 | 0 |
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).
| Percentage of Participants | HOMA-IR<=3 | HOMA-IR >3 |
|---|---|---|
| Genotype I | 83.3 | 72.7 |
| Genotype II | 0 | 0 |
| Genotype III | 16.7 | 27.3 |
| Other | 0 | 0 |
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.
| Percentage of Participants | HOMA-IR<=3 | HOMA-IR >3 |
|---|---|---|
| Genotype I | 51.3 | 54.0 |
| Genotype II | 12.7 | 6.0 |
| Genotype III | 34.8 | 40.0 |
| Other | 1.3 | 0 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pegylated Interferon and Ribavirin | — | 2/250 (0.8%) | 177/250 (70.8%) |
| Event | Pegylated Interferon and Ribavirin |
|---|---|
| Drug Exposure During PregnancyInjury, poisoning and procedural complications | 1/250 |
| Acoustic NeuritisNervous system disorders | 1/250 |
| Event | Pegylated Interferon and Ribavirin |
|---|---|
| Influenza Like IllnessGeneral disorders | 91/250 |
| LeukopeniaBlood and lymphatic system disorders | 90/250 |
| AnaemiaBlood and lymphatic system disorders | 69/250 |
| ThrombocytopeniaBlood and lymphatic system disorders | 50/250 |
| AstheniaGeneral disorders | 31/250 |
| NeutropeniaBlood and lymphatic system disorders | 30/250 |
| Weight DecreasedInvestigations | 26/250 |
| DepressionPsychiatric disorders | 25/250 |
| PyrexiaGeneral disorders | 17/250 |
| AlopeciaSkin and subcutaneous tissue disorders | 14/250 |
| Age, Continuous(years) | Pegylated Interferon and Ribavirin |
|---|---|
| Mean | 36.0 ± 9.78 |
| Sex: Female, Male(Participants) | Pegylated Interferon and Ribavirin |
|---|---|
| Female | 104 |
| Male | 146 |
No study locations are listed for this record.
This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Merck Sharp & Dohme LLC