An observational study in Hepatitis C, Chronic, sponsored by Hoffmann-La Roche. Completed at 12 sites in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-06-21.
Sponsored by Hoffmann-La Roche · Observational
This single arm study will investigate the predictive value of a week 4 virological response on sustained virological response in patients with chronic hepatitis C, genotype 2 or 3, treated with PEGASYS + Copegus. Eligible patients will be treated with PEGASYS 180 micrograms/week sc + Copegus 800mg/day po; those who have a virological response at week 4 will continue to be treated for 24 weeks, followed by a 24 week treatment-free follow-up. Non-responders at week 4 will be entered into a separate protocol (MV21371) to receive PEGASYS + Copegus for 24 or 48 weeks. The anticipated time on study treatment is 3-12 months, and the target sample size is 100 individuals.
2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's enrollment of 262 is close to the median of 250 across 687 observational studies indexed under Hepatitis A.
Browse Hepatitis A studies →Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.
Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participants with serologically proven chronic hepatitis C and genotype 2 or 3, with or without cirrhosis and compensated liver disease (Child-Pugh A cirrhosis.)
Exclusion Criteria:
Drug: peginterferon alfa-2a [Pegasys] · Drug: ribavirin [Copegus]
180 micrograms/week sc for 24 weeks
800mg po daily for 24 weeks
Percentage of Participants With Sustained Virological Response at Week 48
Sustained Virological Response (SVR) is defined as participants with undetectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) at 24 weeks after the last dose of study drug. The detection limit of HCV RNA was 15 international units (IU) per milliliter (mL) by qualitative polymerase chain reaction (PCR).
Time frame: At Week 48
Percentage of Participants With Rapid Virological Response at Week 4
Rapid Virological Response (RVR) is defined as participants with) undetectable HCV RNA at 4 weeks after initiation of the treatment period. The detection limit of HCV RNA was 15 IU/mL by qualitative PCR.
Time frame: At Week 4
Percentage of Participants With Virological Response at Week 24
Virological response is defined as participants with undetectable HCV RNA after the last dose of study drug (Week 24).
Time frame: At Week 24
Percentage of Participants With Virological Relapse
Virological relapse is defined as participants with virological response (undetectable HCV RNA) but did not achieve SVR.
Time frame: At week 48
Percentage of Participants With Positive Predictive Value
Positive predictive value is defined as participants with RVR who did not achieve SVR.
Time frame: At Week 48
Number of Participants With Any Adverse Events and Any Serious Adverse Events
An any adverse events (AEs) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An serious adverse events (SAEs) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.
Time frame: Up to 48 weeks
Mean Percent Change From Baseline in Hematology Parameters at Weeks 2, 4, 12, 24, and 48
Hematology parameters included hemoglobin, hematocrit, leukocytes, neutrophils and platelets.
Time frame: At Baseline (Day 0), Week 2, Week 4, Week 12, Week 24 and Week 48
Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48
Biochemistry parameters included alanine transaminase (ALT), aspartate transaminase (AST), gamma-glutamyl transpeptidase (Gamma-GT),fasting cholesterol, blood glucose, insulin, total bilirubin, creatinine, triglycerides, homeostatic model assessment score, prothrombin time (PT) and international normalized ratio (INR). The homeostatic model assessment (HOMA) score is a method used to quantify insulin resistance. HOMA score = (fasting glucose in mg/dL × fasting insulin in μIU/mL) / 405. A normal participant can have a HOMA score up to 3. A patient with a score of \>3 is definitely insulin resistance. Low HOMA score indicate high insulin resistance, whereas high HOMA score indicate low insulin resistance.
Time frame: Baseline, Week 4, Week 12, Week 24 and Week 48
A total of 262 participants were enrolled from 13 centers in Brazil. This study was conducted between 26 November 2008 and 19 November 2010.
| Milestone | Peginterferon Alfa-2a + Ribavirin |
|---|---|
| Started | 262 |
| Completed | 168 |
| Not completed | 94 |
| Withdrew: Detectable hcv rna after week 4 | 82 |
| Withdrew: Adverse event | 5 |
| Withdrew: Refused treatment | 2 |
| Withdrew: Lost to follow-up | 1 |
| Withdrew: Treatment never started | 1 |
| Withdrew: Hcv rna not detected at baseline and sae | 1 |
| Withdrew: Withdrawal by subject | 2 |
Sustained Virological Response (SVR) is defined as participants with undetectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) at 24 weeks after the last dose of study drug. The detection limit of HCV RNA was 15 international units (IU) per milliliter (mL) by qualitative polymerase chain reaction (PCR).
| Percentage of participants | Peginterferon Alfa-2a + Ribavirin |
|---|---|
| Percentage of Participants With Sustained Virological Response at Week 48 | 52.7 (46.6 to 58.6) |
Rapid Virological Response (RVR) is defined as participants with) undetectable HCV RNA at 4 weeks after initiation of the treatment period. The detection limit of HCV RNA was 15 IU/mL by qualitative PCR.
| Percentage of participants | Peginterferon Alfa-2a + Ribavirin |
|---|---|
| Percentage of Participants With Rapid Virological Response at Week 4 | 56.9 (50.8 to 62.7) |
Virological response is defined as participants with undetectable HCV RNA after the last dose of study drug (Week 24).
| Percentage of participants | Peginterferon Alfa-2a + Ribavirin |
|---|---|
| Percentage of Participants With Virological Response at Week 24 | 56.9 (50.8 to 62.7) |
Virological relapse is defined as participants with virological response (undetectable HCV RNA) but did not achieve SVR.
| Percentage of participants | Peginterferon Alfa-2a + Ribavirin |
|---|---|
| Percentage of Participants With Virological Relapse | 9.4 (5.7 to 15.2) |
Positive predictive value is defined as participants with RVR who did not achieve SVR.
| percentage of participants | Peginterferon Alfa-2a + Ribavirin |
|---|---|
| Percentage of Participants With Positive Predictive Value | 85.2 (78.7 to 90.0) |
An any adverse events (AEs) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An serious adverse events (SAEs) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.
| participants | Peginterferon Alfa-2a + Ribavirin |
|---|---|
| Any AEs | 196 |
| Any SAEs | 13 |
Hematology parameters included hemoglobin, hematocrit, leukocytes, neutrophils and platelets.
| Percent change | Peginterferon Alfa-2a + Ribavirin |
|---|---|
| Hemoglobin, Week 2 ( n =257) | -8.4 ± 0.5 |
| Hemoglobin, Week 4 (n=259) | -15.7 ± 0.6 |
| Hemoglobin, Week 12 (n=157) | -19.6 ± 0.7 |
| Hemoglobin, Week 24 (n=156) | -20.7 ± 0.8 |
| Hemoglobin, Week 48 (n=110) | -2.2 ± 0.6 |
| Hematocrit, Week 2 ( n = 255) | -8.1 ± 0.5 |
| Hematocrit, Week 4 (n = 257) | -14.5 ± 0.5 |
| Hematocrit, Week 12 (n = 156) | -17.7 ± 0.7 |
| Hematocrit, Week 24 (n = 155) | -17.9 ± 0.8 |
| Hematocrit, Week 48 (n=110) | -2.3 ± 0.6 |
| Leukocytes, Week 2 ( n = 256) | -33.2 ± 1.2 |
| Leukocytes, Week 4 (n = 258) | -43.4 ± 1 |
| Leukocytes, Week 12 (n = 157) | -48.1 ± 2.1 |
| Leukocytes, Week 24 (n = 156) | -52.1 ± 1.4 |
| Leukocytes, Week 48 (n = 110) | 0.3 ± 2.5 |
| Neutrophils, Week 2 ( n = 256) | -42.9 ± 2.4 |
| Neutrophils, Week 4 (n = 258) | -48 ± 2.5 |
| Neutrophils, Week 12 (n = 157) | -47.3 ± 4.1 |
| Neutrophils, Week 24 (n = 156) | -53.6 ± 2 |
| Neutrophils, Week 48 (n = 110) | 4.5 ± 3.7 |
| Platelets, Week 2 ( n = 257) | -18.3 ± 1.7 |
| Platelets, Week 4 (n = 259) | -20.4 ± 1.5 |
| Platelets, Week 12 (n = 157) | -26.7 ± 2.4 |
| Platelets, Week 24 (n = 155) | -27.6 ± 1.9 |
| Platelets, Week 48 (n = 110) | 4 ± 4.3 |
Biochemistry parameters included alanine transaminase (ALT), aspartate transaminase (AST), gamma-glutamyl transpeptidase (Gamma-GT),fasting cholesterol, blood glucose, insulin, total bilirubin, creatinine, triglycerides, homeostatic model assessment score, prothrombin time (PT) and international normalized ratio (INR). The homeostatic model assessment (HOMA) score is a method used to quantify insulin resistance. HOMA score = (fasting glucose in mg/dL × fasting insulin in μIU/mL) / 405. A normal participant can have a HOMA score up to 3. A patient with a score of \>3 is definitely insulin resistance. Low HOMA score indicate high insulin resistance, whereas high HOMA score indicate low insulin resistance.
| Percent change | Peginterferon Alfa-2a + Ribavirin |
|---|---|
| ALT, Week 4 ( n = 257) | -28.5 ± 4.8 |
| ALT, Week 12 (n = 159) | -30.4 ± 5.5 |
| ALT, Week 24 (n = 156) | -30 ± 8.6 |
| ALT, Week 48 (n = 125) | -61.8 ± 3.1 |
| AST, Week 4 ( n = 256) | -19.6 ± 2.7 |
| AST, Week 12 (n = 159) | -10.2 ± 4.9 |
| AST, Week 24 (n = 156) | -7.6 ± 8.4 |
| AST, Week 48 (n = 125) | -47.2 ± 2.9 |
| Gamma-GT, Week 4 ( n = 243) | 11.8 ± 3.3 |
| Gamma-GT, Week 12 (n = 151) | 32.5 ± 7.9 |
| Gamma-GT, Week 24 (n = 149) | 69.2 ± 25.3 |
| Gamma-GT, Week 48 (n = 121) | -33.4 ± 3.5 |
| Fasting cholesterol, Week 4 ( n = 214) | -1 ± 1.6 |
| Fasting cholesterol, Week 12 (n = 130) | -1.4 ± 2.4 |
| Fasting cholesterol, Week 24 (n = 123) | 0.6 ± 2.7 |
| Fasting cholesterol, Week 48 (n = 97) | 15.6 ± 2.7 |
| Fasting blood glucose, Week 4 ( n = 229) | -3.5 ± 1.1 |
| Fasting blood glucose, Week 12 (n = 135) | -1.8 ± 2.5 |
| Fasting blood glucose, Week 24 (n = 136) | 1.3 ± 2.4 |
| Fasting blood glucose, Week 48 (n = 111) | -1.2 ± 2.1 |
| Fasting insulin, Week 4 ( n = 131) | 22.9 ± 11.3 |
| Fasting insulin, Week 12 (n = 79) | 11.1 ± 11.6 |
| Fasting insulin, Week 24 (n = 74) | -12.2 ± 5.8 |
| Fasting insulin, Week 48 (n = 68) | 18.3 ± 16.7 |
| Total bilirubin, Week 4 ( n = 234) | 32.8 ± 4.4 |
| Total bilirubin, Week 12 (n = 148) | 19.3 ± 5.3 |
| Total bilirubin, Week 24 (n = 123) | 0 ± 3.9 |
| Total bilirubin, Week 48 (n = 108) | -1.7 ± 4.5 |
| Creatinine, Week 4 ( n = 239) | -1.82 ± 0.99 |
| Creatinine, Week 12 (n = 138) | -2.71 ± 1.43 |
| Creatinine, Week 24 (n = 133) | -3.55 ± 1.55 |
| Creatinine, Week 48 (n = 116) | 5.89 ± 1.78 |
| Fasting triglycerides, Week 4 ( n = 212) | 44.7 ± 4.8 |
| Fasting triglycerides, Week 12 (n = 128) | 56 ± 7.2 |
| Fasting triglycerides, Week 24 (n = 121) | 58.1 ± 7.3 |
| Fasting triglycerides, Week 48 (n = 92) | 22 ± 6.5 |
| HOMA score, Week 4 ( n = 46) | 12.6 ± 23.3 |
| HOMA score, Week 12 (n = 37) | 10.3 ± 20.6 |
| HOMA score, Week 24 (n = 28) | -14.6 ± 11.6 |
| HOMA score, Week 48 (n = 20) | 10.9 ± 19.3 |
| PT, Week 4 ( n = 55) | -1.9 ± 0.7 |
| PT, Week 12 (n = 31) | -2.6 ± 1 |
| PT, Week 24 (n = 26) | -3.5 ± 1.7 |
| PT, Week 48 (n = 30) | -4.1 ± 1 |
| INR, Week 4 ( n = 151) | 0.1 ± 1.3 |
| INR, Week 12 (n = 73) | -1.1 ± 0.8 |
| INR, Week 24 (n = 73) | -1.5 ± 1.1 |
| INR, Week 48 (n = 71) | -3.2 ± 0.8 |
Collected over Up to 48 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Peginterferon Alfa-2a + Ribavirin | — | 13/262 (5%) | 179/262 (68.3%) |
| Event | Peginterferon Alfa-2a + Ribavirin |
|---|---|
| Upper gastrointestinal haemorrhageGastrointestinal disorders | 3/262 |
| Abdominal painGastrointestinal disorders | 1/262 |
| Anorectal operationGastrointestinal disorders | 1/262 |
| AppendicitisInfections and infestations | 1/262 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 1/262 |
| CellulitisInfections and infestations | 1/262 |
| Hepatic cirrhosisHepatobiliary disorders | 1/262 |
| NeutropeniaBlood and lymphatic system disorders | 1/262 |
| PneumoniaInfections and infestations | 1/262 |
| Salivary gland massGastrointestinal disorders | 1/262 |
| Event | Peginterferon Alfa-2a + Ribavirin |
|---|---|
| HeadacheNervous system disorders | 69/262 |
| PyrexiaGeneral disorders | 51/262 |
| AstheniaGeneral disorders | 42/262 |
| Decreased appetiteMetabolism and nutrition disorders | 42/262 |
| MyalgiaMusculoskeletal and connective tissue disorders | 42/262 |
| FatigueGeneral disorders | 32/262 |
| PruritusSkin and subcutaneous tissue disorders | 30/262 |
| AnaemiaBlood and lymphatic system disorders | 27/262 |
| NauseaGastrointestinal disorders | 27/262 |
| Influenza like illnessGeneral disorders | 23/262 |
Intention-to-treat (ITT) population included all participants who received at least one dose of study drug.
| Age, Continuous(Years) | Peginterferon Alfa-2a + Ribavirin |
|---|---|
| Mean | 49.7 ± 9.9 |
| Sex: Female, Male(Participants) | Peginterferon Alfa-2a + Ribavirin |
|---|---|
| Female | 118 |
| Male | 144 |
This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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