Trial Outcomes & Findings for Study of HCV Genotype 1 Patients in the UK Treated With ViraferonPeg and Rebetol (Study P05269)(COMPLETED) (NCT NCT00724373)
NCT ID: NCT00724373
Last Updated: 2015-09-25
Results Overview
Identify subgroups of genotype 1 participants to better understand factors affecting response rates \& treatment outcomes \& to provide predictive models of refractory or responsive phenotypes to aid in HCV treatment, management, \& drug development. Treatment success is defined as those who had achieved sustained virological response (i.e. undetectable viraemia 24 weeks post therapy completion).
COMPLETED
442 participants
Data will be collected from the start of first exposure to pegylated interferon alfa-2b and ribavirin combination therapy. Participants who have successfully completed treatment will have data collected for a follow-up period of at least 24 weeks.
2015-09-25
Participant Flow
Participant milestones
| Measure |
Participants With Genotype 1 Hepatitis C Virus Infection.
Participants with genotype 1 Hepatitis C Virus (HCV) infection who have been treated with pegylated interferon alfa-2b and ribavirin in the preceding 48 months
|
|---|---|
|
Overall Study
STARTED
|
442
|
|
Overall Study
COMPLETED
|
271
|
|
Overall Study
NOT COMPLETED
|
171
|
Reasons for withdrawal
| Measure |
Participants With Genotype 1 Hepatitis C Virus Infection.
Participants with genotype 1 Hepatitis C Virus (HCV) infection who have been treated with pegylated interferon alfa-2b and ribavirin in the preceding 48 months
|
|---|---|
|
Overall Study
Adverse Event
|
41
|
|
Overall Study
Lack of Efficacy
|
82
|
|
Overall Study
Lost to Follow-up
|
7
|
|
Overall Study
Non-compliance
|
2
|
|
Overall Study
HCV RNA negative after 4 weeks
|
9
|
|
Overall Study
Participant moved away
|
1
|
|
Overall Study
Responder at 12 weeks, PCR + at 24 weeks
|
2
|
|
Overall Study
Only to have 24 week regimen
|
1
|
|
Overall Study
Viral Relapse
|
1
|
|
Overall Study
Acute HCV infection
|
1
|
|
Overall Study
Drug Relapse
|
1
|
|
Overall Study
Tolerability
|
23
|
Baseline Characteristics
Study of HCV Genotype 1 Patients in the UK Treated With ViraferonPeg and Rebetol (Study P05269)(COMPLETED)
Baseline characteristics by cohort
| Measure |
Participants With Genotype 1 Hepatitis C Virus Infection.
n=442 Participants
Participants with genotype 1 Hepatitis C Virus (HCV) infection who have been treated with pegylated interferon alfa-2b and ribavirin in the preceding 48 months
|
|---|---|
|
Age, Customized
|
43 Years
STANDARD_DEVIATION 10.13 • n=5 Participants
|
|
Sex/Gender, Customized
Female
|
143 participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
296 participants
n=5 Participants
|
|
Sex/Gender, Customized
Gender information missing
|
3 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
442 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Data will be collected from the start of first exposure to pegylated interferon alfa-2b and ribavirin combination therapy. Participants who have successfully completed treatment will have data collected for a follow-up period of at least 24 weeks.Population: Number of participants who had treatment success.
Identify subgroups of genotype 1 participants to better understand factors affecting response rates \& treatment outcomes \& to provide predictive models of refractory or responsive phenotypes to aid in HCV treatment, management, \& drug development. Treatment success is defined as those who had achieved sustained virological response (i.e. undetectable viraemia 24 weeks post therapy completion).
Outcome measures
| Measure |
Participants With Genotype 1 Hepatitis C Virus Infection.
n=243 Participants
Participants with genotype 1 Hepatitis C Virus (HCV) infection who have been treated with pegylated interferon alfa-2b and ribavirin in the preceding 48 months
|
|---|---|
|
Participants With Treatment Success
Genotype 1a
|
117 Participants
|
|
Participants With Treatment Success
Genotype 1b
|
63 Participants
|
|
Participants With Treatment Success
Genotype 1a and 1b
|
4 Participants
|
|
Participants With Treatment Success
Genotype 1c
|
0 Participants
|
|
Participants With Treatment Success
Genotype 1 subgroup unspecified
|
59 Participants
|
Adverse Events
Pegylated Interferon Alfa-2b and Ribavirin
Serious adverse events
| Measure |
Pegylated Interferon Alfa-2b and Ribavirin
n=442 participants at risk
|
|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.90%
4/442 • Number of events 5
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
0.45%
2/442 • Number of events 2
|
|
Cardiac disorders
ANGINA PECTORIS
|
0.23%
1/442 • Number of events 1
|
|
Cardiac disorders
SUPRAVENTRICULAR TACHYCARDIA
|
0.23%
1/442 • Number of events 1
|
|
Endocrine disorders
HYPOTHYROIDISM
|
0.23%
1/442 • Number of events 1
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.23%
1/442 • Number of events 1
|
|
Gastrointestinal disorders
GASTRITIS
|
0.23%
1/442 • Number of events 1
|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
|
0.23%
1/442 • Number of events 2
|
|
Gastrointestinal disorders
OESOPHAGEAL VARICES HAEMORRHAGE
|
0.23%
1/442 • Number of events 1
|
|
Gastrointestinal disorders
VOMITING
|
0.23%
1/442 • Number of events 1
|
|
General disorders
FATIGUE
|
0.23%
1/442 • Number of events 1
|
|
Immune system disorders
SARCOIDOSIS
|
0.23%
1/442 • Number of events 1
|
|
Infections and infestations
PNEUMONIA PNEUMOCOCCAL
|
0.23%
1/442 • Number of events 1
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
0.23%
1/442 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
0.23%
1/442 • Number of events 1
|
|
Nervous system disorders
SYNCOPE
|
0.23%
1/442 • Number of events 1
|
|
Psychiatric disorders
ACUTE PSYCHOSIS
|
0.90%
4/442 • Number of events 4
|
|
Psychiatric disorders
ANXIETY
|
0.23%
1/442 • Number of events 1
|
|
Psychiatric disorders
DEPRESSION
|
0.23%
1/442 • Number of events 1
|
|
Psychiatric disorders
HALLUCINATION
|
0.23%
1/442 • Number of events 1
|
|
Psychiatric disorders
PARANOIA
|
0.23%
1/442 • Number of events 1
|
|
Psychiatric disorders
SUICIDAL IDEATION
|
0.23%
1/442 • Number of events 1
|
|
Psychiatric disorders
SUICIDE ATTEMPT
|
0.45%
2/442 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
0.23%
1/442 • Number of events 1
|
Other adverse events
Adverse event data not reported
Additional Information
Senior Vice President,Global Clinical Development
Merck Sharp & Dohme Corp.
Results disclosure agreements
- Principal investigator is a sponsor employee All data will be the property of the Sponsor. Although under no obligation, it is asked that the investigator discuss any publication with the sponsor prior to release and obtain written consent. The sponsor recognises the right of the investigator to publish the results upon study completion. However, it is asked that the investigator send a draft to the sponsor 30 days in advance of submission in order to obtain approval.
- Publication restrictions are in place
Restriction type: OTHER