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Efficacy of Peginterferon Alfa-2b (SCH 054031) vs Glycyrrhizin in Interferon (IFN)-Treated Patients With Chronic Hepatitis C and F2/F3 Liver Fibrosis (P04773)

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ClinicalTrials.gov Identifier: NCT00686881
Recruitment Status : Terminated (This study was terminated due to low enrollment)
First Posted : May 30, 2008
Results First Posted : March 6, 2012
Last Update Posted : April 6, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatitis C, Chronic
Interventions Biological: Peginterferon alfa-2b (PegIFN-2b)
Drug: Comparator: Stronger neo minophagen C (SNMC)
Enrollment 261
Recruitment Details  
Pre-assignment Details  
Arm/Group Title PegIFN-2b SNMC
Hide Arm/Group Description Participants receiving peginterferon alfa-2b (PegIFN-2b) at 0.5 ug/kg subcutaneously (SC) once a week for up to 156 weeks. Participants receiving stronger neo minophagen C (SNMC) 40 mL by intravenous (IV) injection or IV infusion 3 times weekly for up to 156 weeks.
Period Title: Overall Study
Started 127 [1] 134 [2]
Completed 45 53
Not Completed 82 81
Reason Not Completed
Withdrawal by Subject             11             18
Lost to Follow-up             0             1
Treatment-related adverse event             10             9
Met discontinuation criteria             5             0
Onset of malignant tumor             11             11
Lack of Efficacy             4             3
Physician Decision             1             0
Circumstances of site             1             1
Did not meet protocol eligibility             1             0
Irregular visits             1             0
Study discontinuation             35             32
Never received study drug             2             6
[1]
After randomization, 2 participants withdrew consent and did not receive study drug.
[2]
After randomization, 6 participants withdrew consent and did not receive study drug.
Arm/Group Title PegIFN-2b SNMC Total
Hide Arm/Group Description Participants receiving peginterferon alfa-2b (PegIFN-2b) at 0.5 ug/kg subcutaneously (SC) once a week for up to 156 weeks. Participants receiving stronger neo minophagen C (SNMC) 40 mL by intravenous (IV) injection or IV infusion 3 times weekly for up to 156 weeks. Total of all reporting groups
Overall Number of Baseline Participants 125 127 252
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 125 participants 127 participants 252 participants
59.8  (9.5) 60.7  (8.9) 60.3  (9.2)
[1]
Measure Description: Of the 261 randomized participants, 253 received study drug; 1 of these participants in the SNMC Arm had no data available after initial treatment and is excluded from study analyses.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 125 participants 127 participants 252 participants
Female
60
  48.0%
65
  51.2%
125
  49.6%
Male
65
  52.0%
62
  48.8%
127
  50.4%
[1]
Measure Description: Of the 261 randomized participants, 253 received study drug; 1 of these participants in the SNMC Arm had no data available after initial treatment and is excluded from study analyses.
Region of Enrollment   [1] 
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 125 participants 127 participants 252 participants
125 127 252
[1]
Measure Description: Of the 261 randomized participants, 253 received study drug; 1 of these participants in the SNMC Arm had no data available after initial treatment and is excluded from study analyses.
1.Primary Outcome
Title Number of Participants With Change in Metavir Fibrosis Score
Hide Description Metavir fibrosis score is a 5-point scale based on the amount of fibrosis in the liver, ranging from F0 (best, no fibrosis) to F4 (worst, cirrhosis).
Time Frame Baseline and discontinuation of treatment (up to 156 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants excluding 2 participants on the PegIFN-2B arm and 1 participant on the SNMC arm for whom baseline data were non-evaluable or for whom no post-baseline data were available.
Arm/Group Title PegIFN-2b SNMC
Hide Arm/Group Description:
Participants receiving peginterferon alfa-2b (PegIFN-2b) at 0.5 ug/kg subcutaneously (SC) once a week for up to 156 weeks.
Participants receiving stronger neo minophagen C (SNMC) 40 mL by intravenous (IV) injection or IV infusion 3 times weekly for up to 156 weeks.
Overall Number of Participants Analyzed 123 126
Measure Type: Number
Unit of Measure: Participants
Participants with ≥1grade lower score (improved) 13 11
Participants with no change in score 79 79
Participants with ≥1 grade higher score (worsened) 31 36
2.Secondary Outcome
Title Number of Participants With Alanine Aminotransferase (ALT) Normalization of >16 Weeks Duration
Hide Description The ALT was judged to have been normalized when the ALT level was 35 IU/L or below.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants except 1 SNMC participant who had no available data after initial treatment.
Arm/Group Title PegIFN-2b SNMC
Hide Arm/Group Description:
Participants receiving PegIFN-2b at 0.5 ug/kg subcutaneously (SC) once a week for up to 156 weeks.
Participants receiving SNMC 40 mL by intravenous (IV) injection or IV infusion 3 times weekly for up to 156 weeks.
Overall Number of Participants Analyzed 125 127
Measure Type: Number
Unit of Measure: Participants
9 2
3.Secondary Outcome
Title Number of Participants With Change in Metavir Inflammation Score
Hide Description Metavir inflammation score is a 4-point scale based on the severity of inflammation in the liver, ranging from A0 (best, no activity) to A3 (worst, severe activity).
Time Frame Baseline and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants excluding 3 participants on the PegIFN-2b arm and 1 participant on the SNMC arm for whom baseline data were non-evaluable or for whom no post-baseline data were available.
Arm/Group Title PegIFN-2b SNMC
Hide Arm/Group Description:
Participants receiving peginterferon alfa-2b (PegIFN-2b) at 0.5 ug/kg subcutaneously (SC) once a week for up to 156 weeks.
Participants receiving stronger neo minophagen C (SNMC) 40 mL by intravenous (IV) injection or IV infusion 3 times weekly for up to 156 weeks.
Overall Number of Participants Analyzed 122 126
Measure Type: Number
Unit of Measure: Participants
Participants with ≥1grade lower score (improved) 48 23
Participants with no change in score 55 61
Participants with ≥1grade higher score (worsened) 19 42
Time Frame [Not Specified]
Adverse Event Reporting Description All treated participants except one SNMC participant who had no available data after initial treatment.
 
Arm/Group Title PegIFN-2b SNMC
Hide Arm/Group Description

Participants receiving PegIFN-2b at 0.5 ug/kg subcutaneously (SC) once a week for

up to 156 weeks.

Participants receiving SNMC 40 mL by intravenous (IV) injection or IV infusion 3 times weekly for up

to 156 weeks.

All-Cause Mortality
PegIFN-2b SNMC
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
PegIFN-2b SNMC
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   32/125 (25.60%)      23/127 (18.11%)    
Blood and lymphatic system disorders     
IDIOPATHIC THROMBOCYTOPENIC PURPURA  1  0/125 (0.00%)  0 1/127 (0.79%)  1
Cardiac disorders     
PRINZMETAL ANGINA  1  0/125 (0.00%)  0 1/127 (0.79%)  1
Ear and labyrinth disorders     
DEAFNESS NEUROSENSORY  1  1/125 (0.80%)  1 0/127 (0.00%)  0
MENIERE'S DISEASE  1  1/125 (0.80%)  1 0/127 (0.00%)  0
Gastrointestinal disorders     
COLONIC POLYP  1  0/125 (0.00%)  0 1/127 (0.79%)  1
DUODENAL ULCER  1  1/125 (0.80%)  1 0/127 (0.00%)  0
GINGIVAL BLEEDING  1  1/125 (0.80%)  1 0/127 (0.00%)  0
PANCREATITIS  1  1/125 (0.80%)  1 0/127 (0.00%)  0
PANCREATITIS ACUTE  1  1/125 (0.80%)  1 0/127 (0.00%)  0
VARICES OESOPHAGEAL  1  1/125 (0.80%)  1 0/127 (0.00%)  0
General disorders     
PYREXIA  1  1/125 (0.80%)  1 0/127 (0.00%)  0
Infections and infestations     
APPENDICITIS  1  1/125 (0.80%)  1 0/127 (0.00%)  0
BRONCHIECTASIS  1  1/125 (0.80%)  1 0/127 (0.00%)  0
BRONCHOPNEUMONIA  1  1/125 (0.80%)  1 0/127 (0.00%)  0
PYELONEPHRITIS  1  1/125 (0.80%)  1 0/127 (0.00%)  0
PYELONEPHRITIS ACUTE  1  1/125 (0.80%)  1 0/127 (0.00%)  0
SEPSIS  1  0/125 (0.00%)  0 1/127 (0.79%)  1
Injury, poisoning and procedural complications     
ANKLE FRACTURE  1  1/125 (0.80%)  1 0/127 (0.00%)  0
FRACTURED SACRUM  1  1/125 (0.80%)  1 0/127 (0.00%)  0
HAND FRACTURE  1  1/125 (0.80%)  1 0/127 (0.00%)  0
HUMERUS FRACTURE  1  0/125 (0.00%)  0 1/127 (0.79%)  1
LOWER LIMB FRACTURE  1  1/125 (0.80%)  1 0/127 (0.00%)  0
MENISCUS LESION  1  0/125 (0.00%)  0 1/127 (0.79%)  1
POST PROCEDURAL HAEMORRHAGE  1  1/125 (0.80%)  1 0/127 (0.00%)  0
SKIN LACERATION  1  1/125 (0.80%)  1 0/127 (0.00%)  0
SUBDURAL HAEMATOMA  1  1/125 (0.80%)  1 1/127 (0.79%)  1
TENDON RUPTURE  1  0/125 (0.00%)  0 1/127 (0.79%)  1
Metabolism and nutrition disorders     
DECREASED APPETITE  1  1/125 (0.80%)  1 0/127 (0.00%)  0
DIABETES MELLITUS  1  1/125 (0.80%)  1 1/127 (0.79%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
GASTRIC CANCER  1  0/125 (0.00%)  0 1/127 (0.79%)  1
HEPATIC NEOPLASM MALIGNANT  1  8/125 (6.40%)  8 10/127 (7.87%)  10
LARGE INTESTINE CARCINOMA  1  1/125 (0.80%)  1 0/127 (0.00%)  0
METASTASES TO LUNG  1  1/125 (0.80%)  1 0/127 (0.00%)  0
OVARIAN NEOPLASM  1  0/125 (0.00%)  0 1/127 (0.79%)  1
PANCREATIC CARCINOMA  1  1/125 (0.80%)  1 0/127 (0.00%)  0
RECTAL CANCER  1  0/125 (0.00%)  0 1/127 (0.79%)  1
RENAL CELL CARCINOMA  1  1/125 (0.80%)  1 0/127 (0.00%)  0
Nervous system disorders     
CEREBRAL HAEMORRHAGE  1  1/125 (0.80%)  1 1/127 (0.79%)  1
INTRAVENTRICULAR HAEMORRHAGE  1  0/125 (0.00%)  0 1/127 (0.79%)  1
LACUNAR INFARCTION  1  1/125 (0.80%)  1 0/127 (0.00%)  0
PARALYSIS  1  0/125 (0.00%)  0 1/127 (0.79%)  1
Psychiatric disorders     
ANXIETY DISORDER  1  0/125 (0.00%)  0 1/127 (0.79%)  1
Renal and urinary disorders     
CALCULUS URETERIC  1  1/125 (0.80%)  1 0/127 (0.00%)  0
Skin and subcutaneous tissue disorders     
PSORIASIS  1  1/125 (0.80%)  1 0/127 (0.00%)  0
Vascular disorders     
ANEURYSM RUPTURED  1  1/125 (0.80%)  1 0/127 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
PegIFN-2b SNMC
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   125/125 (100.00%)      123/127 (96.85%)    
Cardiac disorders     
PALPITATIONS  1  8/125 (6.40%)  13 6/127 (4.72%)  7
Eye disorders     
ASTHENOPIA  1  7/125 (5.60%)  7 4/127 (3.15%)  4
CONJUNCTIVITIS  1  13/125 (10.40%)  19 2/127 (1.57%)  2
Gastrointestinal disorders     
ABDOMINAL DISCOMFORT  1  16/125 (12.80%)  21 9/127 (7.09%)  16
ABDOMINAL DISTENSION  1  7/125 (5.60%)  9 3/127 (2.36%)  4
ABDOMINAL PAIN  1  35/125 (28.00%)  79 22/127 (17.32%)  32
ABDOMINAL PAIN UPPER  1  14/125 (11.20%)  15 14/127 (11.02%)  21
CONSTIPATION  1  32/125 (25.60%)  40 10/127 (7.87%)  10
DENTAL CARIES  1  7/125 (5.60%)  10 8/127 (6.30%)  8
DIARRHOEA  1  35/125 (28.00%)  63 17/127 (13.39%)  31
NAUSEA  1  40/125 (32.00%)  76 20/127 (15.75%)  22
PERIODONTITIS  1  8/125 (6.40%)  8 6/127 (4.72%)  6
STOMATITIS  1  15/125 (12.00%)  22 7/127 (5.51%)  11
TOOTHACHE  1  6/125 (4.80%)  6 8/127 (6.30%)  12
VOMITING  1  9/125 (7.20%)  10 9/127 (7.09%)  10
General disorders     
CHILLS  1  50/125 (40.00%)  76 12/127 (9.45%)  14
INJECTION SITE ERYTHEMA  1  34/125 (27.20%)  43 1/127 (0.79%)  1
INJECTION SITE PRURITUS  1  45/125 (36.00%)  61 3/127 (2.36%)  4
MALAISE  1  97/125 (77.60%)  166 51/127 (40.16%)  81
OEDEMA PERIPHERAL  1  9/125 (7.20%)  9 12/127 (9.45%)  13
PYREXIA  1  87/125 (69.60%)  171 25/127 (19.69%)  36
THIRST  1  6/125 (4.80%)  6 9/127 (7.09%)  12
Infections and infestations     
CYSTITIS  1  7/125 (5.60%)  10 5/127 (3.94%)  7
GASTROENTERITIS  1  4/125 (3.20%)  6 8/127 (6.30%)  10
NASOPHARYNGITIS  1  77/125 (61.60%)  157 81/127 (63.78%)  256
ORAL HERPES  1  7/125 (5.60%)  9 4/127 (3.15%)  6
Injury, poisoning and procedural complications     
CONTUSION  1  13/125 (10.40%)  18 6/127 (4.72%)  9
PROCEDURAL PAIN  1  15/125 (12.00%)  16 12/127 (9.45%)  13
TOOTH FRACTURE  1  9/125 (7.20%)  10 1/127 (0.79%)  1
Investigations     
ALANINE AMINOTRANSFERASE INCREASED  1  34/125 (27.20%)  42 16/127 (12.60%)  21
ALPHA 1 FOETOPROTEIN INCREASED  1  4/125 (3.20%)  6 9/127 (7.09%)  10
ASPARTATE AMINOTRANSFERASE INCREASED  1  47/125 (37.60%)  58 21/127 (16.54%)  26
BASOPHIL COUNT INCREASED  1  18/125 (14.40%)  42 27/127 (21.26%)  46
BILIRUBIN CONJUGATED INCREASED  1  5/125 (4.00%)  5 10/127 (7.87%)  19
BLOOD ALKALINE PHOSPHATASE INCREASED  1  12/125 (9.60%)  16 16/127 (12.60%)  24
BLOOD BILIRUBIN INCREASED  1  3/125 (2.40%)  3 8/127 (6.30%)  13
BLOOD POTASSIUM DECREASED  1  12/125 (9.60%)  15 17/127 (13.39%)  27
BLOOD POTASSIUM INCREASED  1  5/125 (4.00%)  6 8/127 (6.30%)  10
BLOOD PRESSURE INCREASED  1  12/125 (9.60%)  15 22/127 (17.32%)  28
BLOOD THYROID STIMULATING HORMONE INCREASED  1  29/125 (23.20%)  38 14/127 (11.02%)  19
C-REACTIVE PROTEIN INCREASED  1  16/125 (12.80%)  18 14/127 (11.02%)  19
EOSINOPHIL COUNT INCREASED  1  32/125 (25.60%)  52 32/127 (25.20%)  53
GAMMA-GLUTAMYLTRANSFERASE INCREASED  1  30/125 (24.00%)  37 23/127 (18.11%)  32
HAEMATOCRIT DECREASED  1  40/125 (32.00%)  60 10/127 (7.87%)  11
HAEMOGLOBIN DECREASED  1  41/125 (32.80%)  52 11/127 (8.66%)  13
HYALURONIC ACID INCREASED  1  62/125 (49.60%)  90 46/127 (36.22%)  70
LYMPHOCYTE COUNT DECREASED  1  80/125 (64.00%)  134 45/127 (35.43%)  107
LYMPHOCYTE COUNT INCREASED  1  28/125 (22.40%)  51 34/127 (26.77%)  69
MONOCYTE COUNT INCREASED  1  13/125 (10.40%)  14 8/127 (6.30%)  13
NEUTROPHIL COUNT DECREASED  1  62/125 (49.60%)  111 9/127 (7.09%)  12
NEUTROPHIL COUNT INCREASED  1  31/125 (24.80%)  48 50/127 (39.37%)  77
PLATELET COUNT DECREASED  1  74/125 (59.20%)  109 19/127 (14.96%)  24
RED BLOOD CELL COUNT DECREASED  1  41/125 (32.80%)  57 7/127 (5.51%)  7
TRI-IODOTHYRONINE FREE DECREASED  1  11/125 (8.80%)  12 6/127 (4.72%)  6
WEIGHT DECREASED  1  14/125 (11.20%)  14 5/127 (3.94%)  5
WHITE BLOOD CELL COUNT DECREASED  1  68/125 (54.40%)  104 9/127 (7.09%)  15
WHITE BLOOD CELL COUNT INCREASED  1  8/125 (6.40%)  13 21/127 (16.54%)  21
Metabolism and nutrition disorders     
DECREASED APPETITE  1  57/125 (45.60%)  91 22/127 (17.32%)  30
Musculoskeletal and connective tissue disorders     
ARTHRALGIA  1  72/125 (57.60%)  123 31/127 (24.41%)  41
BACK PAIN  1  26/125 (20.80%)  35 31/127 (24.41%)  50
MUSCLE SPASMS  1  9/125 (7.20%)  16 13/127 (10.24%)  22
MUSCULOSKELETAL PAIN  1  7/125 (5.60%)  7 9/127 (7.09%)  13
MUSCULOSKELETAL STIFFNESS  1  14/125 (11.20%)  16 7/127 (5.51%)  7
MYALGIA  1  68/125 (54.40%)  108 24/127 (18.90%)  39
PAIN IN EXTREMITY  1  10/125 (8.00%)  10 9/127 (7.09%)  11
TENOSYNOVITIS  1  2/125 (1.60%)  2 8/127 (6.30%)  8
Nervous system disorders     
DIZZINESS  1  19/125 (15.20%)  25 15/127 (11.81%)  21
HEADACHE  1  82/125 (65.60%)  164 42/127 (33.07%)  73
HYPOAESTHESIA  1  8/125 (6.40%)  8 8/127 (6.30%)  10
Psychiatric disorders     
INSOMNIA  1  49/125 (39.20%)  78 15/127 (11.81%)  17
Respiratory, thoracic and mediastinal disorders     
COUGH  1  13/125 (10.40%)  19 15/127 (11.81%)  17
EPISTAXIS  1  11/125 (8.80%)  35 10/127 (7.87%)  17
OROPHARYNGEAL DISCOMFORT  1  7/125 (5.60%)  7 2/127 (1.57%)  2
OROPHARYNGEAL PAIN  1  14/125 (11.20%)  28 12/127 (9.45%)  21
UPPER RESPIRATORY TRACT INFLAMMATION  1  9/125 (7.20%)  12 11/127 (8.66%)  17
Skin and subcutaneous tissue disorders     
ALOPECIA  1  42/125 (33.60%)  51 3/127 (2.36%)  5
DERMATITIS CONTACT  1  9/125 (7.20%)  11 8/127 (6.30%)  9
ECZEMA  1  11/125 (8.80%)  14 12/127 (9.45%)  20
PRURITUS  1  48/125 (38.40%)  94 24/127 (18.90%)  33
PRURITUS GENERALISED  1  12/125 (9.60%)  19 7/127 (5.51%)  8
RASH  1  42/125 (33.60%)  53 18/127 (14.17%)  25
Vascular disorders     
HYPERTENSION  1  13/125 (10.40%)  13 21/127 (16.54%)  23
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
This study was prematurely discontinued because of low enrollment.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp..
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00686881    
Other Study ID Numbers: P04773
JPC-05-356-30
First Submitted: May 27, 2008
First Posted: May 30, 2008
Results First Submitted: February 3, 2012
Results First Posted: March 6, 2012
Last Update Posted: April 6, 2017