Trial Outcomes & Findings for Efficacy of Nitazoxanide in the Treatment of Chronic Hepatitis C Virus (HCV) (NCT NCT01276756)
NCT ID: NCT01276756
Last Updated: 2013-05-03
Results Overview
sustained virological response is defined as a negative HCV PCR at 180 days after the end of treatment (End of treatment being at 48 weeks for Group A, 52 weeks for Group B). For any patient who stopped treatment prematurely (e.g. due to adverse events) SVR was defined as a negative HCV PCR (polymerase chain reaction) at 180 days after the last dose of all medications (interferon, ribavirin and nitazoxanide)
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
100 participants
Primary outcome timeframe
180 days (+- 7 days) after the end of treatment. (48 weeks for Group A, 52 weeks for Group B, or after the last dose of treatment for patients who stopped prematurely).
Results posted on
2013-05-03
Participant Flow
Participant milestones
| Measure |
Standard of Care
Group A: comprises 50 treatment-naive chronic hepatitis c patients who will receive the standard of care treatment: peginterferon Alfa 2a 160 ug once weekly and weight-based ribavirin 1000 or 1200 mg/day (based on body weight \< 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
|
Triple Therapy
Group B: comprises 50 treatment-naive chronic HCV patients who will receive oral Nitazoxanide 500 mg twice daily for 4 weeks (lead-in phase) followed by triple therapy, nitazoxanide 500 mg twice daily plus peginterferon alfa-2a (160ug once weekly) and weight-based ribavirin 1000-1200 mg daily (based on body weight \< 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
45
|
48
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
Reasons for withdrawal
| Measure |
Standard of Care
Group A: comprises 50 treatment-naive chronic hepatitis c patients who will receive the standard of care treatment: peginterferon Alfa 2a 160 ug once weekly and weight-based ribavirin 1000 or 1200 mg/day (based on body weight \< 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
|
Triple Therapy
Group B: comprises 50 treatment-naive chronic HCV patients who will receive oral Nitazoxanide 500 mg twice daily for 4 weeks (lead-in phase) followed by triple therapy, nitazoxanide 500 mg twice daily plus peginterferon alfa-2a (160ug once weekly) and weight-based ribavirin 1000-1200 mg daily (based on body weight \< 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
Adverse Event
|
3
|
2
|
Baseline Characteristics
Efficacy of Nitazoxanide in the Treatment of Chronic Hepatitis C Virus (HCV)
Baseline characteristics by cohort
| Measure |
Standard of Care
n=50 Participants
Group A: comprises 50 treatment-naive chronic hepatitis c patients who will receive the standard of care treatment: peginterferon Alfa 2a 160 ug once weekly and weight-based ribavirin 1000 or 1200 mg/day (based on body weight \< 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
|
Triple Therapy
n=50 Participants
Group B: comprises 50 treatment-naive chronic HCV patients who will receive oral Nitazoxanide 500 mg twice daily for 4 weeks (lead-in phase) followed by triple therapy, nitazoxanide 500 mg twice daily plus peginterferon alfa-2a (160ug once weekly) and weight-based ribavirin 1000-1200 mg daily (based on body weight \< 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
50 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
45.46 years
STANDARD_DEVIATION 6.88 • n=5 Participants
|
45.42 years
STANDARD_DEVIATION 8.36 • n=7 Participants
|
45.44 years
STANDARD_DEVIATION 7.61 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
|
Region of Enrollment
Egypt
|
50 participants
n=5 Participants
|
50 participants
n=7 Participants
|
100 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 180 days (+- 7 days) after the end of treatment. (48 weeks for Group A, 52 weeks for Group B, or after the last dose of treatment for patients who stopped prematurely).Population: All was intention-to-treat (ITT) analysis. Any patient who received at least one dose of interferon was included in the analyses.The only 2 dropouts (lost to follow-up) were calculated as failures.
sustained virological response is defined as a negative HCV PCR at 180 days after the end of treatment (End of treatment being at 48 weeks for Group A, 52 weeks for Group B). For any patient who stopped treatment prematurely (e.g. due to adverse events) SVR was defined as a negative HCV PCR (polymerase chain reaction) at 180 days after the last dose of all medications (interferon, ribavirin and nitazoxanide)
Outcome measures
| Measure |
Standard of Care
n=50 Participants
Group A: comprises 50 treatment-naive chronic hepatitis c patients who will receive the standard of care treatment: peginterferon Alfa 2a 160 ug once weekly and weight-based ribavirin 1000 or 1200 mg/day (based on body weight \< 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
|
Triple Therapy
n=50 Participants
Group B: comprises 50 treatment-naive chronic HCV patients who will receive oral Nitazoxanide 500 mg twice daily for 4 weeks (lead-in phase) followed by triple therapy, nitazoxanide 500 mg twice daily plus peginterferon alfa-2a (160ug once weekly) and weight-based ribavirin 1000-1200 mg daily (based on body weight \< 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
|
|---|---|---|
|
Sustained Virologic Response
|
24 participants
0.5
|
25 participants
0.5
|
SECONDARY outcome
Timeframe: 28 - 33 days after start of Pegylated interferon and ribavirinPopulation: Only 1 patient in "standard of care" arm and 3 patients in the "triple therapy" arm missed doing the PCR test at week 4. These patients were thus not included in this particular analysis.
A rapid virologic response is defined as a negative HCV PCR 4 weeks after treatment
Outcome measures
| Measure |
Standard of Care
n=49 Participants
Group A: comprises 50 treatment-naive chronic hepatitis c patients who will receive the standard of care treatment: peginterferon Alfa 2a 160 ug once weekly and weight-based ribavirin 1000 or 1200 mg/day (based on body weight \< 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
|
Triple Therapy
n=47 Participants
Group B: comprises 50 treatment-naive chronic HCV patients who will receive oral Nitazoxanide 500 mg twice daily for 4 weeks (lead-in phase) followed by triple therapy, nitazoxanide 500 mg twice daily plus peginterferon alfa-2a (160ug once weekly) and weight-based ribavirin 1000-1200 mg daily (based on body weight \< 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
|
|---|---|---|
|
Rapid Virological Response
|
30 participants
|
25 participants
|
SECONDARY outcome
Timeframe: 90 ± 7 days from the start of pegylated interferon and ribavirinPopulation: ITT. Any patient who received at least one dose of interferon was included in the analyses.
A complete early virologic response is defined as a negative HCV PCR 90 days after the start of pegylated interferon. A partial early virologic response is defined as a decrease of 2 or more log in HCV PCR at 90 days after the start of pegylated interferon
Outcome measures
| Measure |
Standard of Care
n=50 Participants
Group A: comprises 50 treatment-naive chronic hepatitis c patients who will receive the standard of care treatment: peginterferon Alfa 2a 160 ug once weekly and weight-based ribavirin 1000 or 1200 mg/day (based on body weight \< 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
|
Triple Therapy
n=50 Participants
Group B: comprises 50 treatment-naive chronic HCV patients who will receive oral Nitazoxanide 500 mg twice daily for 4 weeks (lead-in phase) followed by triple therapy, nitazoxanide 500 mg twice daily plus peginterferon alfa-2a (160ug once weekly) and weight-based ribavirin 1000-1200 mg daily (based on body weight \< 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
|
|---|---|---|
|
Early Virological Response
Complete early virologic response
|
35 participants
|
36 participants
|
|
Early Virological Response
Partial early virologic response
|
5 participants
|
0 participants
|
|
Early Virological Response
No early virologic response response
|
10 participants
|
14 participants
|
SECONDARY outcome
Timeframe: 48 weeks +- 7 days after starting pegylated interferon and ribavirinPopulation: ITT. Any patient who received at least one dose of interferon was included in the analyses.
An end-of-treatment response is defined as a negative HCV PCR at 48 weeks after the start of pegylated interferon and ribavirin
Outcome measures
| Measure |
Standard of Care
n=50 Participants
Group A: comprises 50 treatment-naive chronic hepatitis c patients who will receive the standard of care treatment: peginterferon Alfa 2a 160 ug once weekly and weight-based ribavirin 1000 or 1200 mg/day (based on body weight \< 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
|
Triple Therapy
n=50 Participants
Group B: comprises 50 treatment-naive chronic HCV patients who will receive oral Nitazoxanide 500 mg twice daily for 4 weeks (lead-in phase) followed by triple therapy, nitazoxanide 500 mg twice daily plus peginterferon alfa-2a (160ug once weekly) and weight-based ribavirin 1000-1200 mg daily (based on body weight \< 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
|
|---|---|---|
|
End-of-treatment Response
|
31 participants
|
29 participants
|
SECONDARY outcome
Timeframe: throughout the period of treatment and up to 90 days after end of triple therapyThe occurence of adverse events that could be linked temporally and reasonably to the administration of the tested drug.
Outcome measures
| Measure |
Standard of Care
n=50 Participants
Group A: comprises 50 treatment-naive chronic hepatitis c patients who will receive the standard of care treatment: peginterferon Alfa 2a 160 ug once weekly and weight-based ribavirin 1000 or 1200 mg/day (based on body weight \< 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
|
Triple Therapy
n=50 Participants
Group B: comprises 50 treatment-naive chronic HCV patients who will receive oral Nitazoxanide 500 mg twice daily for 4 weeks (lead-in phase) followed by triple therapy, nitazoxanide 500 mg twice daily plus peginterferon alfa-2a (160ug once weekly) and weight-based ribavirin 1000-1200 mg daily (based on body weight \< 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
|
|---|---|---|
|
Safety of Nitazoxanide (Number of Participants Experiencing Adverse Events)
|
50 participants
|
47 participants
|
Adverse Events
Standard of Care
Serious events: 0 serious events
Other events: 50 other events
Deaths: 0 deaths
Triple Therapy
Serious events: 0 serious events
Other events: 47 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Standard of Care
n=50 participants at risk
Group A: comprises 50 treatment-naive chronic hepatitis c patients who will receive the standard of care treatment: peginterferon Alfa 2a 160 ug once weekly and weight-based ribavirin 1000 or 1200 mg/day (based on body weight \< 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
|
Triple Therapy
n=50 participants at risk
Group B: comprises 50 treatment-naive chronic HCV patients who will receive oral Nitazoxanide 500 mg twice daily for 4 weeks (lead-in phase) followed by triple therapy, nitazoxanide 500 mg twice daily plus peginterferon alfa-2a (160ug once weekly) and weight-based ribavirin 1000-1200 mg daily (based on body weight \< 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
|
|---|---|---|
|
General disorders
Fever
|
98.0%
49/50
|
90.0%
45/50
|
|
General disorders
Fatigue
|
90.0%
45/50
|
84.0%
42/50
|
|
Gastrointestinal disorders
dyspepsia
|
14.0%
7/50
|
32.0%
16/50
|
|
Gastrointestinal disorders
anorexia
|
26.0%
13/50
|
32.0%
16/50
|
|
Gastrointestinal disorders
constipation
|
8.0%
4/50
|
10.0%
5/50
|
|
Gastrointestinal disorders
diarrhea
|
2.0%
1/50
|
2.0%
1/50
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal pains
|
40.0%
20/50
|
50.0%
25/50
|
|
Skin and subcutaneous tissue disorders
itching
|
30.0%
15/50
|
32.0%
16/50
|
|
Skin and subcutaneous tissue disorders
rash
|
0.00%
0/50
|
4.0%
2/50
|
|
Psychiatric disorders
depression
|
8.0%
4/50
|
8.0%
4/50
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
12.0%
6/50
|
4.0%
2/50
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
0.00%
0/50
|
8.0%
4/50
|
|
Psychiatric disorders
insomnia
|
10.0%
5/50
|
4.0%
2/50
|
|
General disorders
headache
|
32.0%
16/50
|
48.0%
24/50
|
|
Blood and lymphatic system disorders
Neutropenia (<1000/ml)
|
22.0%
11/50
|
12.0%
6/50
|
|
Blood and lymphatic system disorders
Anemia (Hgb <10g/dl)
|
32.0%
16/50
|
30.0%
15/50
|
|
Nervous system disorders
facial palsy
|
2.0%
1/50
|
0.00%
0/50
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place