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Safety and Efficacy of the Therapeutic Vaccine GI-5005 Combined With Pegylated Interferon Plus Ribavirin Standard of Care Therapy Versus Standard of Care Alone in Patients With Genotype 1 Chronic Hepatitis C Infection

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ClinicalTrials.gov Identifier: NCT00606086
Recruitment Status : Completed
First Posted : February 1, 2008
Results First Posted : June 3, 2014
Last Update Posted : June 27, 2014
Sponsor:
Information provided by (Responsible Party):
GlobeImmune

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Genotype 1 Chronic Hepatitis C
Interventions Drug: GI-5005
Drug: Pegylated Interferon and Ribavirin
Enrollment 140
Recruitment Details 38 Investigators in the U.S. (30 in U.S., 3 in Europe, 5 in India) were recruited to participate in this study. First subject was screened on November 12, 2007 and the last subject was screened on March 7, 2011.
Pre-assignment Details  
Arm/Group Title Arm 1: Peg-IFN/Ribavirin Plus GI-5005 Arm 2: Peg-IFN/Ribavirin or Peg-IFN/Ribavirin Plus GI-5005
Hide Arm/Group Description Subjects were given GI-5005 alone for 12 weeks (5 weekly followed by 2 monthly doses). After completion of GI-5005 monotherapy run in period peg-IFN/ribavirin (SOC) therapy was added to continued monthly administration of GI-5005 and the subjects were treated for subsequent 12 week period. At the end of this period, subjects who achieve an EVR continued to receive GI-5005 plus SOC therapy for an additional 36 weeks (naive subjects) or an additional 60 weeks (non-responder subjects). Subjects who did not achieve an EVR were followed for safety during a 36 week off treatment period. Any subject who discontinued SOC therapy due to intolerance at or prior to EVR assessment was treated with GI-5005 monotherapy for up to a total of 72 weeks. Subjects were treated with 12 weeks of SOC (Peg-IFN plus Ribavirin) therapy. Subjects who achieve an EVR continued to receive SOC therapy for an additional 36 weeks (naive subjects) or an additional 60 weeks (non-responder subjects). Subjects who did not achieve an EVR, GI-5005 was added to SOC therapy and study drug administration continued for up to an additional 62 weeks. Subjects who discontinued SOC therapy due to intolerance were treated with GI-5005 monotherapy for up to 72 weeks.
Period Title: Overall Study
Started 72 68
Completed 60 53
Not Completed 12 15
Reason Not Completed
Adverse Event             1             1
Lost to Follow-up             4             8
Protocol Violation             1             0
Withdrawal by Subject             5             3
Non-compliance             0             1
Randomized, not treated             1             2
Arm/Group Title Arm 1: Peg-IFN/Ribavirin Plus GI-5005 Arm 2: Peg-IFN/Ribavirin or Peg-IFN/Ribavirin Plus GI-5005 Total
Hide Arm/Group Description Subjects were given GI-5005 alone for 12 weeks (5 weekly followed by 2 monthly doses). After completion of GI-5005 monotherapy run in period peg-IFN/ribavirin (SOC) therapy was added to continued monthly administration of GI-5005 and the subjects were treated for subsequent 12 week period. At the end of this period, subjects who achieve an EVR continued to receive GI-5005 plus SOC therapy for an additional 36 weeks (naive subjects) or an additional 60 weeks (non-responder subjects). Subjects who did not achieve an EVR were followed for safety during a 36 week off treatment period. Any subject who discontinued SOC therapy due to intolerance at or prior to EVR assessment was treated with GI-5005 monotherapy for up to a total of 72 weeks. Subjects were treated with 12 weeks of SOC (Peg-IFN plus Ribavirin) therapy. Subjects who achieve an EVR continued to receive SOC therapy for an additional 36 weeks (naive subjects) or an additional 60 weeks (non-responder subjects). Subjects who did not achieve an EVR, GI-5005 was added to SOC therapy and study drug administration continued for up to an additional 62 weeks. Subjects who discontinued SOC therapy due to intolerance were treated with GI-5005 monotherapy for up to 72 weeks. Total of all reporting groups
Overall Number of Baseline Participants 72 68 140
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 72 participants 68 participants 140 participants
48
(20 to 74)
49
(20 to 68)
48
(20 to 74)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 72 participants 68 participants 140 participants
Female
30
  41.7%
23
  33.8%
53
  37.9%
Male
42
  58.3%
45
  66.2%
87
  62.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 72 participants 68 participants 140 participants
United States 62 62 124
Europe 6 4 10
India 4 2 6
1.Primary Outcome
Title EVR (Early Virologic Response)
Hide Description Early Virologic Response (EVR) is a response measured by the reduction of virus in the blood after 12 weeks of treatment.
Time Frame At 12 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
One hundred forty subjects were randomized, only 133 subjects received at least one dose of study drug. Subjects who did not receive at least one dose of study drug were removed from the analysis.
Arm/Group Title Arm 1: Peg-IFN/Ribavirin Plus GI-5005 Arm 2: Peg-IFN/Ribavirin or Peg-IFN/Ribavirin Plus GI-5005
Hide Arm/Group Description:
Subjects were given GI-5005 alone for 12 weeks (5 weekly followed by 2 monthly doses). After completion of GI-5005 monotherapy run in period peg-IFN/ribavirin (SOC) therapy was added to continued monthly administration of GI-5005 and the subjects were treated for subsequent 12 week period. At the end of this period, subjects who achieve an EVR continued to receive GI-5005 plus SOC therapy for an additional 36 weeks (naive subjects) or an additional 60 weeks (non-responder subjects). Subjects who did not achieve an EVR were followed for safety during a 36 week off treatment period. Any subject who discontinued SOC therapy due to intolerance at or prior to EVR assessment was treated with GI-5005 monotherapy for up to a total of 72 weeks.
Subjects were treated with 12 weeks of SOC (Peg-IFN plus Ribavirin) therapy. Subjects who achieve an EVR continued to receive SOC therapy for an additional 36 weeks (naive subjects) or an additional 60 weeks (non-responder subjects). Subjects who did not achieve an EVR, GI-5005 was added to SOC therapy and study drug administration continued for up to an additional 62 weeks. Subjects who discontinued SOC therapy due to intolerance were treated with GI-5005 monotherapy for up to 72 weeks.
Overall Number of Participants Analyzed 68 65
Measure Type: Number
Unit of Measure: percentage of participants
79.4 78.5
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1: Peg-IFN/Ribavirin Plus GI-5005, Arm 2: Peg-IFN/Ribavirin or Peg-IFN/Ribavirin Plus GI-5005
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments [Not Specified]
Method Cochran-Mantel-Haenszel test
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm 1: Peg-IFN/Ribavirin Plus GI-5005 Arm 2: Peg-IFN/Ribavirin or Peg-IFN/Ribavirin Plus GI-5005
Hide Arm/Group Description Subjects were given GI-5005 alone for 12 weeks (5 weekly followed by 2 monthly doses). After completion of GI-5005 monotherapy run in period peg-IFN/ribavirin (SOC) therapy was added to continued monthly administration of GI-5005 and the subjects were treated for subsequent 12 week period. At the end of this period, subjects who achieve an EVR continued to receive GI-5005 plus SOC therapy for an additional 36 weeks (naive subjects) or an additional 60 weeks (non-responder subjects). Subjects who did not achieve an EVR were followed for safety during a 36 week off treatment period. Any subject who discontinued SOC therapy due to intolerance at or prior to EVR assessment was treated with GI-5005 monotherapy for up to a total of 72 weeks. Subjects were treated with 12 weeks of SOC (Peg-IFN plus Ribavirin) therapy. Subjects who achieve an EVR continued to receive SOC therapy for an additional 36 weeks (naive subjects) or an additional 60 weeks (non-responder subjects). Subjects who did not achieve an EVR, GI-5005 was added to SOC therapy and study drug administration continued for up to an additional 62 weeks. Subjects who discontinued SOC therapy due to intolerance were treated with GI-5005 monotherapy for up to 72 weeks.
All-Cause Mortality
Arm 1: Peg-IFN/Ribavirin Plus GI-5005 Arm 2: Peg-IFN/Ribavirin or Peg-IFN/Ribavirin Plus GI-5005
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Arm 1: Peg-IFN/Ribavirin Plus GI-5005 Arm 2: Peg-IFN/Ribavirin or Peg-IFN/Ribavirin Plus GI-5005
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   14/71 (19.72%)      7/65 (10.77%)    
Blood and lymphatic system disorders     
Haemolytic anaemia  1/71 (1.41%)  1 0/65 (0.00%)  0
Gastrointestinal disorders     
Peritoneal Haemorrhage  1/71 (1.41%)  1 0/65 (0.00%)  0
General disorders     
Chest pain  2/71 (2.82%)  2 0/65 (0.00%)  0
Influenza like illness  1/71 (1.41%)  1 0/65 (0.00%)  0
Non-cardiac chest pain  2/71 (2.82%)  2 0/65 (0.00%)  0
Hepatobiliary disorders     
Biliary colic  0/71 (0.00%)  0 1/65 (1.54%)  1
Cholelithiasis  1/71 (1.41%)  1 0/65 (0.00%)  0
Infections and infestations     
Abscess  1/71 (1.41%)  1 0/65 (0.00%)  0
Appendicitis  1/71 (1.41%)  1 0/65 (0.00%)  0
Cellulitis  1/71 (1.41%)  1 0/65 (0.00%)  0
Injury, poisoning and procedural complications     
Fall  1/71 (1.41%)  1 0/65 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Intervertebral disc protrusion  0/71 (0.00%)  0 1/65 (1.54%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Basal cell carcinoma  1/71 (1.41%)  1 0/65 (0.00%)  0
Laryngeal cancer  0/71 (0.00%)  0 1/65 (1.54%)  1
Squamous cell carcinoma of skin  1/71 (1.41%)  1 0/65 (0.00%)  0
Nervous system disorders     
Convulsion  0/71 (0.00%)  0 1/65 (1.54%)  1
Dementia  0/71 (0.00%)  0 1/65 (1.54%)  1
Sciatica  1/71 (1.41%)  1 0/65 (0.00%)  0
Psychiatric disorders     
Delirium  1/71 (1.41%)  1 0/65 (0.00%)  0
Mental status changes  0/71 (0.00%)  0 1/65 (1.54%)  1
Renal and urinary disorders     
Renal failure acute  0/71 (0.00%)  0 1/65 (1.54%)  1
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease  0/71 (0.00%)  0 1/65 (1.54%)  1
Social circumstances     
Drug abuser  1/71 (1.41%)  1 0/65 (0.00%)  0
Vascular disorders     
Deep vein thrombosis  1/71 (1.41%)  1 0/65 (0.00%)  0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm 1: Peg-IFN/Ribavirin Plus GI-5005 Arm 2: Peg-IFN/Ribavirin or Peg-IFN/Ribavirin Plus GI-5005
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   70/71 (98.59%)      65/65 (100.00%)    
Blood and lymphatic system disorders     
Anaemia  43/71 (60.56%)  44/65 (67.69%) 
Leucopenia  4/71 (5.63%)  3/65 (4.62%) 
neutropenia  57/71 (80.28%)  51/65 (78.46%) 
Eye disorders     
Dry eye  5/71 (7.04%)  2/65 (3.08%) 
Gastrointestinal disorders     
abdominal pain  10/71 (14.08%)  8/65 (12.31%) 
abdominal pain upper  5/71 (7.04%)  2/65 (3.08%) 
constipation  9/71 (12.68%)  6/65 (9.23%) 
Diarrhoea  15/71 (21.13%)  18/65 (27.69%) 
Dry mouth  9/71 (12.68%)  10/65 (15.38%) 
Dyspepsia  7/71 (9.86%)  3/65 (4.62%) 
Gastroesophageal reflux disease  2/71 (2.82%)  6/65 (9.23%) 
Haemorrhoids  0/71 (0.00%)  4/65 (6.15%) 
Nausea  28/71 (39.44%)  26/65 (40.00%) 
vomitting  14/71 (19.72%)  9/65 (13.85%) 
General disorders     
Asthenia  4/71 (5.63%)  3/65 (4.62%) 
Chest pain  5/71 (7.04%)  5/65 (7.69%) 
Chills  14/71 (19.72%)  16/65 (24.62%) 
Fatigue  44/71 (61.97%)  46/65 (70.77%) 
Influenza like illness  14/71 (19.72%)  14/65 (21.54%) 
Injection site bruising  6/71 (8.45%)  1/65 (1.54%) 
Injection site erythema  30/71 (42.25%)  21/65 (32.31%) 
Injection site induration  8/71 (11.27%)  0/65 (0.00%) 
Injection site pain  22/71 (30.99%)  9/65 (13.85%) 
Injection site pruritus  8/71 (11.27%)  1/65 (1.54%) 
Injection site swelling  7/71 (9.86%)  1/65 (1.54%) 
Irritability  16/71 (22.54%)  18/65 (27.69%) 
Malaise  6/71 (8.45%)  1/65 (1.54%) 
Oedema peripheral  5/71 (7.04%)  4/65 (6.15%) 
Pain  11/71 (15.49%)  13/65 (20.00%) 
Pyrexia  20/71 (28.17%)  18/65 (27.69%) 
Hepatobiliary disorders     
Hepatomegaly  1/71 (1.41%)  5/65 (7.69%) 
Infections and infestations     
Bronchitis  4/71 (5.63%)  2/65 (3.08%) 
Herpes simplex  6/71 (8.45%)  2/65 (3.08%) 
Nasopharyngitis  4/71 (5.63%)  1/65 (1.54%) 
Sinusitis  5/71 (7.04%)  5/65 (7.69%) 
Upper respiratory tract infection  11/71 (15.49%)  8/65 (12.31%) 
Urinary tract infection  9/71 (12.68%)  6/65 (9.23%) 
Injury, poisoning and procedural complications     
Contusion  4/71 (5.63%)  3/65 (4.62%) 
Excoriation  4/71 (5.63%)  0/65 (0.00%) 
Investigations     
Blood creatine phosphokinase increased  5/71 (7.04%)  3/65 (4.62%) 
Neutrophil count decreased  4/71 (5.63%)  3/65 (4.62%) 
Weight decreased  11/71 (15.49%)  9/65 (13.85%) 
White blood cell count decreased  4/71 (5.63%)  2/65 (3.08%) 
Metabolism and nutrition disorders     
anorexia  9/71 (12.68%)  3/65 (4.62%) 
Decreased appetite  4/71 (5.63%)  8/65 (12.31%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  13/71 (18.31%)  12/65 (18.46%) 
Back pain  7/71 (9.86%)  14/65 (21.54%) 
Muscle spasms  5/71 (7.04%)  8/65 (12.31%) 
Myalgia  18/71 (25.35%)  16/65 (24.62%) 
Pain in extremity  6/71 (8.45%)  5/65 (7.69%) 
Nervous system disorders     
Amnesia  1/71 (1.41%)  6/65 (9.23%) 
Disturbance in attention  2/71 (2.82%)  6/65 (9.23%) 
Dizziness  10/71 (14.08%)  14/65 (21.54%) 
Dysgeusia  4/71 (5.63%)  1/65 (1.54%) 
Headache  27/71 (38.03%)  29/65 (44.62%) 
Hypoaesthesia  0/71 (0.00%)  4/65 (6.15%) 
Memory impairment  7/71 (9.86%)  0/65 (0.00%) 
Migraine  6/71 (8.45%)  0/65 (0.00%) 
Paraesthesia  3/71 (4.23%)  4/65 (6.15%) 
Psychiatric disorders     
Anxiety  8/71 (11.27%)  13/65 (20.00%) 
Depression  17/71 (23.94%)  23/65 (35.38%) 
Insomnia  22/71 (30.99%)  26/65 (40.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough  14/71 (19.72%)  16/65 (24.62%) 
Dyspnoea  10/71 (14.08%)  8/65 (12.31%) 
Dyspnoea exertional  6/71 (8.45%)  6/65 (9.23%) 
Pharyngolaryngeal pain  5/71 (7.04%)  3/65 (4.62%) 
Productive cough  4/71 (5.63%)  3/65 (4.62%) 
sinus congestion  4/71 (5.63%)  3/65 (4.62%) 
Wheezing  2/71 (2.82%)  4/65 (6.15%) 
Skin and subcutaneous tissue disorders     
Alopecia  7/71 (9.86%)  8/65 (12.31%) 
Dermititis  5/71 (7.04%)  7/65 (10.77%) 
Dry skin  5/71 (7.04%)  6/65 (9.23%) 
Hypotrichosis  1/71 (1.41%)  5/65 (7.69%) 
Puritus  12/71 (16.90%)  15/65 (23.08%) 
Puritus generalized  7/71 (9.86%)  3/65 (4.62%) 
Rash  19/71 (26.76%)  16/65 (24.62%) 
Vascular disorders     
Hypertension  7/71 (9.86%)  0/65 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
PI will not publish or present in any forum any writing or discussion that involves Sponsor intellectual property or clinical trial information until the study has been finalized and all completed case report forms have been delivered to Sponsor. The confidentiality obligations will remain in effect for 5 years from the date of termination or expiration of study agreement.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Operations Manager
Organization: GlobeImmune, Inc.
Phone: 3036252700
EMail: Alicia.Mattson@globeimmune.com
Layout table for additonal information
Responsible Party: GlobeImmune
ClinicalTrials.gov Identifier: NCT00606086    
Other Study ID Numbers: GI-5005-02
First Submitted: January 18, 2008
First Posted: February 1, 2008
Results First Submitted: May 5, 2014
Results First Posted: June 3, 2014
Last Update Posted: June 27, 2014