Trial Outcomes & Findings for 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 (NCT NCT00606086)
NCT ID: NCT00606086
Last Updated: 2014-06-27
Results Overview
Early Virologic Response (EVR) is a response measured by the reduction of virus in the blood after 12 weeks of treatment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
140 participants
Primary outcome timeframe
At 12 weeks of treatment
Results posted on
2014-06-27
Participant Flow
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.
Participant milestones
| Measure |
Arm 1: Peg-IFN/Ribavirin Plus GI-5005
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.
|
Arm 2: Peg-IFN/Ribavirin or Peg-IFN/Ribavirin Plus GI-5005
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 Study
STARTED
|
72
|
68
|
|
Overall Study
COMPLETED
|
60
|
53
|
|
Overall Study
NOT COMPLETED
|
12
|
15
|
Reasons for withdrawal
| Measure |
Arm 1: Peg-IFN/Ribavirin Plus GI-5005
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.
|
Arm 2: Peg-IFN/Ribavirin or Peg-IFN/Ribavirin Plus GI-5005
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 Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
4
|
8
|
|
Overall Study
Withdrawal by Subject
|
5
|
3
|
|
Overall Study
Non-compliance
|
0
|
1
|
|
Overall Study
Randomized, not treated
|
1
|
2
|
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
Arm 1: Peg-IFN/Ribavirin Plus GI-5005
n=72 Participants
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.
|
Arm 2: Peg-IFN/Ribavirin or Peg-IFN/Ribavirin Plus GI-5005
n=68 Participants
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
n=140 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48 years
n=93 Participants
|
49 years
n=4 Participants
|
48 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=93 Participants
|
23 Participants
n=4 Participants
|
53 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=93 Participants
|
45 Participants
n=4 Participants
|
87 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
62 participants
n=93 Participants
|
62 participants
n=4 Participants
|
124 participants
n=27 Participants
|
|
Region of Enrollment
Europe
|
6 participants
n=93 Participants
|
4 participants
n=4 Participants
|
10 participants
n=27 Participants
|
|
Region of Enrollment
India
|
4 participants
n=93 Participants
|
2 participants
n=4 Participants
|
6 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: At 12 weeks of treatmentPopulation: 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.
Early Virologic Response (EVR) is a response measured by the reduction of virus in the blood after 12 weeks of treatment.
Outcome measures
| Measure |
Arm 1: Peg-IFN/Ribavirin Plus GI-5005
n=68 Participants
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.
|
Arm 2: Peg-IFN/Ribavirin or Peg-IFN/Ribavirin Plus GI-5005
n=65 Participants
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.
|
|---|---|---|
|
EVR (Early Virologic Response)
|
79.4 percentage of participants
|
78.5 percentage of participants
|
Adverse Events
Arm 1: Peg-IFN/Ribavirin Plus GI-5005
Serious events: 14 serious events
Other events: 70 other events
Deaths: 0 deaths
Arm 2: Peg-IFN/Ribavirin or Peg-IFN/Ribavirin Plus GI-5005
Serious events: 7 serious events
Other events: 65 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1: Peg-IFN/Ribavirin Plus GI-5005
n=71 participants at risk
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.
|
Arm 2: Peg-IFN/Ribavirin or Peg-IFN/Ribavirin Plus GI-5005
n=65 participants at risk
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.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/71
|
1.5%
1/65 • Number of events 1
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
1.4%
1/71 • Number of events 1
|
0.00%
0/65
|
|
Gastrointestinal disorders
Peritoneal Haemorrhage
|
1.4%
1/71 • Number of events 1
|
0.00%
0/65
|
|
General disorders
Chest pain
|
2.8%
2/71 • Number of events 2
|
0.00%
0/65
|
|
General disorders
Influenza like illness
|
1.4%
1/71 • Number of events 1
|
0.00%
0/65
|
|
General disorders
Non-cardiac chest pain
|
2.8%
2/71 • Number of events 2
|
0.00%
0/65
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/71
|
1.5%
1/65 • Number of events 1
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.4%
1/71 • Number of events 1
|
0.00%
0/65
|
|
Infections and infestations
Abscess
|
1.4%
1/71 • Number of events 1
|
0.00%
0/65
|
|
Infections and infestations
Appendicitis
|
1.4%
1/71 • Number of events 1
|
0.00%
0/65
|
|
Infections and infestations
Cellulitis
|
1.4%
1/71 • Number of events 1
|
0.00%
0/65
|
|
Injury, poisoning and procedural complications
Fall
|
1.4%
1/71 • Number of events 1
|
0.00%
0/65
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
1.4%
1/71 • Number of events 1
|
0.00%
0/65
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
0.00%
0/71
|
1.5%
1/65 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
1.4%
1/71 • Number of events 1
|
0.00%
0/65
|
|
Nervous system disorders
Convulsion
|
0.00%
0/71
|
1.5%
1/65 • Number of events 1
|
|
Nervous system disorders
Dementia
|
0.00%
0/71
|
1.5%
1/65 • Number of events 1
|
|
Nervous system disorders
Sciatica
|
1.4%
1/71 • Number of events 1
|
0.00%
0/65
|
|
Psychiatric disorders
Delirium
|
1.4%
1/71 • Number of events 1
|
0.00%
0/65
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/71
|
1.5%
1/65 • Number of events 1
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/71
|
1.5%
1/65 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/71
|
1.5%
1/65 • Number of events 1
|
|
Social circumstances
Drug abuser
|
1.4%
1/71 • Number of events 1
|
0.00%
0/65
|
|
Vascular disorders
Deep vein thrombosis
|
1.4%
1/71 • Number of events 1
|
0.00%
0/65
|
Other adverse events
| Measure |
Arm 1: Peg-IFN/Ribavirin Plus GI-5005
n=71 participants at risk
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.
|
Arm 2: Peg-IFN/Ribavirin or Peg-IFN/Ribavirin Plus GI-5005
n=65 participants at risk
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.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
60.6%
43/71
|
67.7%
44/65
|
|
Blood and lymphatic system disorders
Leucopenia
|
5.6%
4/71
|
4.6%
3/65
|
|
Blood and lymphatic system disorders
neutropenia
|
80.3%
57/71
|
78.5%
51/65
|
|
Eye disorders
Dry eye
|
7.0%
5/71
|
3.1%
2/65
|
|
Gastrointestinal disorders
abdominal pain
|
14.1%
10/71
|
12.3%
8/65
|
|
Gastrointestinal disorders
abdominal pain upper
|
7.0%
5/71
|
3.1%
2/65
|
|
Gastrointestinal disorders
constipation
|
12.7%
9/71
|
9.2%
6/65
|
|
Gastrointestinal disorders
Diarrhoea
|
21.1%
15/71
|
27.7%
18/65
|
|
Gastrointestinal disorders
Dry mouth
|
12.7%
9/71
|
15.4%
10/65
|
|
Gastrointestinal disorders
Dyspepsia
|
9.9%
7/71
|
4.6%
3/65
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
2.8%
2/71
|
9.2%
6/65
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/71
|
6.2%
4/65
|
|
Gastrointestinal disorders
Nausea
|
39.4%
28/71
|
40.0%
26/65
|
|
Gastrointestinal disorders
vomitting
|
19.7%
14/71
|
13.8%
9/65
|
|
General disorders
Asthenia
|
5.6%
4/71
|
4.6%
3/65
|
|
General disorders
Chest pain
|
7.0%
5/71
|
7.7%
5/65
|
|
General disorders
Chills
|
19.7%
14/71
|
24.6%
16/65
|
|
General disorders
Fatigue
|
62.0%
44/71
|
70.8%
46/65
|
|
General disorders
Influenza like illness
|
19.7%
14/71
|
21.5%
14/65
|
|
General disorders
Injection site bruising
|
8.5%
6/71
|
1.5%
1/65
|
|
General disorders
Injection site erythema
|
42.3%
30/71
|
32.3%
21/65
|
|
General disorders
Injection site induration
|
11.3%
8/71
|
0.00%
0/65
|
|
General disorders
Injection site pain
|
31.0%
22/71
|
13.8%
9/65
|
|
General disorders
Injection site pruritus
|
11.3%
8/71
|
1.5%
1/65
|
|
General disorders
Injection site swelling
|
9.9%
7/71
|
1.5%
1/65
|
|
General disorders
Irritability
|
22.5%
16/71
|
27.7%
18/65
|
|
General disorders
Malaise
|
8.5%
6/71
|
1.5%
1/65
|
|
General disorders
Oedema peripheral
|
7.0%
5/71
|
6.2%
4/65
|
|
General disorders
Pain
|
15.5%
11/71
|
20.0%
13/65
|
|
General disorders
Pyrexia
|
28.2%
20/71
|
27.7%
18/65
|
|
Hepatobiliary disorders
Hepatomegaly
|
1.4%
1/71
|
7.7%
5/65
|
|
Infections and infestations
Bronchitis
|
5.6%
4/71
|
3.1%
2/65
|
|
Infections and infestations
Herpes simplex
|
8.5%
6/71
|
3.1%
2/65
|
|
Infections and infestations
Nasopharyngitis
|
5.6%
4/71
|
1.5%
1/65
|
|
Infections and infestations
Sinusitis
|
7.0%
5/71
|
7.7%
5/65
|
|
Infections and infestations
Upper respiratory tract infection
|
15.5%
11/71
|
12.3%
8/65
|
|
Infections and infestations
Urinary tract infection
|
12.7%
9/71
|
9.2%
6/65
|
|
Injury, poisoning and procedural complications
Contusion
|
5.6%
4/71
|
4.6%
3/65
|
|
Injury, poisoning and procedural complications
Excoriation
|
5.6%
4/71
|
0.00%
0/65
|
|
Investigations
Blood creatine phosphokinase increased
|
7.0%
5/71
|
4.6%
3/65
|
|
Investigations
Neutrophil count decreased
|
5.6%
4/71
|
4.6%
3/65
|
|
Investigations
Weight decreased
|
15.5%
11/71
|
13.8%
9/65
|
|
Investigations
White blood cell count decreased
|
5.6%
4/71
|
3.1%
2/65
|
|
Metabolism and nutrition disorders
anorexia
|
12.7%
9/71
|
4.6%
3/65
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.6%
4/71
|
12.3%
8/65
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
18.3%
13/71
|
18.5%
12/65
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.9%
7/71
|
21.5%
14/65
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
7.0%
5/71
|
12.3%
8/65
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
25.4%
18/71
|
24.6%
16/65
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.5%
6/71
|
7.7%
5/65
|
|
Nervous system disorders
Amnesia
|
1.4%
1/71
|
9.2%
6/65
|
|
Nervous system disorders
Disturbance in attention
|
2.8%
2/71
|
9.2%
6/65
|
|
Nervous system disorders
Dizziness
|
14.1%
10/71
|
21.5%
14/65
|
|
Nervous system disorders
Dysgeusia
|
5.6%
4/71
|
1.5%
1/65
|
|
Nervous system disorders
Headache
|
38.0%
27/71
|
44.6%
29/65
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/71
|
6.2%
4/65
|
|
Nervous system disorders
Memory impairment
|
9.9%
7/71
|
0.00%
0/65
|
|
Nervous system disorders
Migraine
|
8.5%
6/71
|
0.00%
0/65
|
|
Nervous system disorders
Paraesthesia
|
4.2%
3/71
|
6.2%
4/65
|
|
Psychiatric disorders
Anxiety
|
11.3%
8/71
|
20.0%
13/65
|
|
Psychiatric disorders
Depression
|
23.9%
17/71
|
35.4%
23/65
|
|
Psychiatric disorders
Insomnia
|
31.0%
22/71
|
40.0%
26/65
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
19.7%
14/71
|
24.6%
16/65
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
14.1%
10/71
|
12.3%
8/65
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
8.5%
6/71
|
9.2%
6/65
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
7.0%
5/71
|
4.6%
3/65
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.6%
4/71
|
4.6%
3/65
|
|
Respiratory, thoracic and mediastinal disorders
sinus congestion
|
5.6%
4/71
|
4.6%
3/65
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
2.8%
2/71
|
6.2%
4/65
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
9.9%
7/71
|
12.3%
8/65
|
|
Skin and subcutaneous tissue disorders
Dermititis
|
7.0%
5/71
|
10.8%
7/65
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.0%
5/71
|
9.2%
6/65
|
|
Skin and subcutaneous tissue disorders
Hypotrichosis
|
1.4%
1/71
|
7.7%
5/65
|
|
Skin and subcutaneous tissue disorders
Puritus
|
16.9%
12/71
|
23.1%
15/65
|
|
Skin and subcutaneous tissue disorders
Puritus generalized
|
9.9%
7/71
|
4.6%
3/65
|
|
Skin and subcutaneous tissue disorders
Rash
|
26.8%
19/71
|
24.6%
16/65
|
|
Vascular disorders
Hypertension
|
9.9%
7/71
|
0.00%
0/65
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER