Trial Outcomes & Findings for Effects of Pegylated Interferon Alfa-2b and Ribavirin After Orthotopic Liver Transplantation in Subjects With Chronic Hepatitis C Recurrence (P04590AM3)(COMPLETED) (NCT NCT00378599)
NCT ID: NCT00378599
Last Updated: 2017-04-06
Results Overview
Number of participants with SVR at 24-week follow up after treatment with PEG-Intron and Ribavirin in post-orthotopic liver transplant recipients with recurrent HCV.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
125 participants
Primary outcome timeframe
24 weeks after completion of up to 48 weeks of therapy
Results posted on
2017-04-06
Participant Flow
Participant milestones
| Measure |
PEG-Intron Plus Ribavirin
PEG-Intron plus ribavirin treatment for up to 48 weeks with 24-week follow up
|
|---|---|
|
Overall Study
STARTED
|
125
|
|
Overall Study
COMPLETED
|
73
|
|
Overall Study
NOT COMPLETED
|
52
|
Reasons for withdrawal
| Measure |
PEG-Intron Plus Ribavirin
PEG-Intron plus ribavirin treatment for up to 48 weeks with 24-week follow up
|
|---|---|
|
Overall Study
Adverse Event
|
38
|
|
Overall Study
Protocol Violation
|
2
|
|
Overall Study
Treatment failure
|
7
|
|
Overall Study
Withdrawal by Subject
|
5
|
Baseline Characteristics
Effects of Pegylated Interferon Alfa-2b and Ribavirin After Orthotopic Liver Transplantation in Subjects With Chronic Hepatitis C Recurrence (P04590AM3)(COMPLETED)
Baseline characteristics by cohort
| Measure |
PEG-Intron Plus Ribavirin
n=125 Participants
PEG-Intron plus ribavirin treatment for up to 48 weeks with 24-week follow up
|
|---|---|
|
Age, Continuous
|
54.2 years
STANDARD_DEVIATION 5.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
106 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 weeks after completion of up to 48 weeks of therapyPopulation: Intent to Treat (ITT) Data Set: All enrolled subjects who received at least one dose of any study medication (PEG-Intron or Rebetol (RBV)). Analysis of all primary and secondary efficacy endpoints and safety variables was based on the ITT population.
Number of participants with SVR at 24-week follow up after treatment with PEG-Intron and Ribavirin in post-orthotopic liver transplant recipients with recurrent HCV.
Outcome measures
| Measure |
PEG-Intron Plus Ribavirin
n=125 Participants
PEG-Intron plus ribavirin treatment for up to 48 weeks with 24-week follow up
|
|---|---|
|
A Sustained Virologic Response (SVR), Defined as a Plasma HCV RNA Level Below the Lower Level of Quantitation (LLQ) at 24 Weeks Post-treatment
|
36 Participants
Interval 21.1 to 37.6
|
Adverse Events
Pegylated Interferon Alfa-2b and Ribavirin
Serious events: 32 serious events
Other events: 125 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pegylated Interferon Alfa-2b and Ribavirin
n=125 participants at risk
|
|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
4.0%
5/125 • Number of events 5
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
1.6%
2/125 • Number of events 2
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
0.80%
1/125 • Number of events 1
|
|
Blood and lymphatic system disorders
PANCYTOPENIA
|
0.80%
1/125 • Number of events 1
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
1.6%
2/125 • Number of events 2
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.80%
1/125 • Number of events 1
|
|
Ear and labyrinth disorders
VERTIGO
|
0.80%
1/125 • Number of events 1
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.80%
1/125 • Number of events 1
|
|
Gastrointestinal disorders
DIARRHOEA
|
1.6%
2/125 • Number of events 4
|
|
Gastrointestinal disorders
NAUSEA
|
1.6%
2/125 • Number of events 3
|
|
Gastrointestinal disorders
VOMITING
|
2.4%
3/125 • Number of events 4
|
|
General disorders
ASTHENIA
|
0.80%
1/125 • Number of events 1
|
|
General disorders
CHEST PAIN
|
2.4%
3/125 • Number of events 3
|
|
General disorders
CHILLS
|
0.80%
1/125 • Number of events 1
|
|
General disorders
MALAISE
|
1.6%
2/125 • Number of events 2
|
|
General disorders
PYREXIA
|
1.6%
2/125 • Number of events 2
|
|
Hepatobiliary disorders
AUTOIMMUNE HEPATITIS
|
0.80%
1/125 • Number of events 1
|
|
Hepatobiliary disorders
CHOLANGITIS
|
0.80%
1/125 • Number of events 1
|
|
Hepatobiliary disorders
HEPATIC FAILURE
|
0.80%
1/125 • Number of events 1
|
|
Immune system disorders
LIVER TRANSPLANT REJECTION
|
1.6%
2/125 • Number of events 3
|
|
Infections and infestations
APPENDICITIS
|
0.80%
1/125 • Number of events 1
|
|
Infections and infestations
CELLULITIS
|
2.4%
3/125 • Number of events 3
|
|
Infections and infestations
CLOSTRIDIUM DIFFICILE COLITIS
|
1.6%
2/125 • Number of events 2
|
|
Infections and infestations
GASTROENTERITIS
|
0.80%
1/125 • Number of events 1
|
|
Infections and infestations
GASTROENTERITIS VIRAL
|
0.80%
1/125 • Number of events 1
|
|
Infections and infestations
OSTEOMYELITIS
|
0.80%
1/125 • Number of events 1
|
|
Infections and infestations
PNEUMONIA
|
3.2%
4/125 • Number of events 4
|
|
Infections and infestations
SUBCUTANEOUS ABSCESS
|
0.80%
1/125 • Number of events 1
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.80%
1/125 • Number of events 1
|
|
Injury, poisoning and procedural complications
ANASTOMOTIC COMPLICATION
|
0.80%
1/125 • Number of events 1
|
|
Injury, poisoning and procedural complications
CONTUSION
|
0.80%
1/125 • Number of events 1
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL DISCHARGE
|
0.80%
1/125 • Number of events 1
|
|
Investigations
HAEMOGLOBIN DECREASED
|
0.80%
1/125 • Number of events 1
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
2.4%
3/125 • Number of events 3
|
|
Metabolism and nutrition disorders
HYPERKALAEMIA
|
0.80%
1/125 • Number of events 1
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
0.80%
1/125 • Number of events 1
|
|
Nervous system disorders
CONVULSION
|
0.80%
1/125 • Number of events 1
|
|
Nervous system disorders
HEADACHE
|
2.4%
3/125 • Number of events 3
|
|
Nervous system disorders
SYNCOPE
|
0.80%
1/125 • Number of events 1
|
|
Psychiatric disorders
DRUG ABUSE
|
0.80%
1/125 • Number of events 1
|
|
Psychiatric disorders
MENTAL STATUS CHANGES
|
0.80%
1/125 • Number of events 1
|
|
Psychiatric disorders
SUICIDAL IDEATION
|
0.80%
1/125 • Number of events 1
|
|
Renal and urinary disorders
RENAL FAILURE ACUTE
|
0.80%
1/125 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.80%
1/125 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
0.80%
1/125 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
PRODUCTIVE COUGH
|
0.80%
1/125 • Number of events 1
|
|
Social circumstances
TREATMENT NONCOMPLIANCE
|
0.80%
1/125 • Number of events 1
|
|
Surgical and medical procedures
LEG AMPUTATION
|
0.80%
1/125 • Number of events 1
|
|
Surgical and medical procedures
SPLENECTOMY
|
0.80%
1/125 • Number of events 1
|
Other adverse events
| Measure |
Pegylated Interferon Alfa-2b and Ribavirin
n=125 participants at risk
|
|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
72.8%
91/125 • Number of events 162
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
13.6%
17/125 • Number of events 25
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
31.2%
39/125 • Number of events 51
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
12.8%
16/125 • Number of events 20
|
|
Eye disorders
VISION BLURRED
|
8.8%
11/125 • Number of events 11
|
|
Gastrointestinal disorders
ABDOMINAL DISCOMFORT
|
9.6%
12/125 • Number of events 13
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
10.4%
13/125 • Number of events 19
|
|
Gastrointestinal disorders
CONSTIPATION
|
6.4%
8/125 • Number of events 9
|
|
Gastrointestinal disorders
DIARRHOEA
|
40.8%
51/125 • Number of events 73
|
|
Gastrointestinal disorders
DRY MOUTH
|
8.8%
11/125 • Number of events 11
|
|
Gastrointestinal disorders
NAUSEA
|
47.2%
59/125 • Number of events 72
|
|
Gastrointestinal disorders
STOMATITIS
|
12.0%
15/125 • Number of events 15
|
|
Gastrointestinal disorders
VOMITING
|
25.6%
32/125 • Number of events 44
|
|
General disorders
ASTHENIA
|
8.0%
10/125 • Number of events 13
|
|
General disorders
CHILLS
|
22.4%
28/125 • Number of events 28
|
|
General disorders
FATIGUE
|
71.2%
89/125 • Number of events 112
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
14.4%
18/125 • Number of events 22
|
|
General disorders
INJECTION SITE ERYTHEMA
|
12.8%
16/125 • Number of events 17
|
|
General disorders
INJECTION SITE RASH
|
5.6%
7/125 • Number of events 7
|
|
General disorders
IRRITABILITY
|
21.6%
27/125 • Number of events 27
|
|
General disorders
MALAISE
|
5.6%
7/125 • Number of events 11
|
|
General disorders
OEDEMA PERIPHERAL
|
7.2%
9/125 • Number of events 10
|
|
General disorders
PAIN
|
14.4%
18/125 • Number of events 20
|
|
General disorders
PYREXIA
|
28.0%
35/125 • Number of events 49
|
|
Infections and infestations
INFLUENZA
|
6.4%
8/125 • Number of events 8
|
|
Infections and infestations
SINUSITIS
|
5.6%
7/125 • Number of events 9
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
5.6%
7/125 • Number of events 8
|
|
Investigations
BLOOD CREATININE INCREASED
|
8.0%
10/125 • Number of events 13
|
|
Investigations
WEIGHT DECREASED
|
23.2%
29/125 • Number of events 30
|
|
Metabolism and nutrition disorders
ANOREXIA
|
12.0%
15/125 • Number of events 16
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
26.4%
33/125 • Number of events 38
|
|
Metabolism and nutrition disorders
HYPERKALAEMIA
|
6.4%
8/125 • Number of events 9
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
20.8%
26/125 • Number of events 29
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
16.0%
20/125 • Number of events 22
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
8.8%
11/125 • Number of events 13
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
16.8%
21/125 • Number of events 22
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
8.8%
11/125 • Number of events 11
|
|
Nervous system disorders
DIZZINESS
|
24.8%
31/125 • Number of events 36
|
|
Nervous system disorders
HEADACHE
|
63.2%
79/125 • Number of events 98
|
|
Nervous system disorders
HYPOAESTHESIA
|
6.4%
8/125 • Number of events 10
|
|
Nervous system disorders
TREMOR
|
5.6%
7/125 • Number of events 7
|
|
Psychiatric disorders
ANXIETY
|
15.2%
19/125 • Number of events 21
|
|
Psychiatric disorders
DEPRESSION
|
23.2%
29/125 • Number of events 36
|
|
Psychiatric disorders
INSOMNIA
|
31.2%
39/125 • Number of events 41
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
14.4%
18/125 • Number of events 23
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
25.6%
32/125 • Number of events 37
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA EXERTIONAL
|
12.0%
15/125 • Number of events 17
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
9.6%
12/125 • Number of events 14
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY TRACT CONGESTION
|
5.6%
7/125 • Number of events 7
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
10.4%
13/125 • Number of events 13
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
9.6%
12/125 • Number of events 12
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
14.4%
18/125 • Number of events 19
|
|
Skin and subcutaneous tissue disorders
RASH
|
25.6%
32/125 • Number of events 41
|
|
Vascular disorders
HYPERTENSION
|
6.4%
8/125 • Number of events 8
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Lead investigator agrees not to publish or publicly present any interim results of the Study without prior written consent of the sponsor. Lead investigator further agrees to provide 45 days written notice to the sponsor prior to submission for publication or presentation to permit the sponsor to review copies of abstracts or manuscripts for publication, which report any results of the Study. Sponsor shall have the right to review and comment on any presentation, including editorial rights.
- Publication restrictions are in place
Restriction type: OTHER