Chronic Liver Disease With Tuberclosis Clinical Trial
Official title:
Study of Efficacy and Safety of Modified Anti-tubercular Regimens in Treatment of Tuberculosis in Patients With Underlying Compensated and Decompensated Chronic Liver Disease
During the Study:
- Subject is required to visit every week for the first 2 months and then every month
till completion of study or as and when required
- The usual symptomatic and supportive treatment of Chronic Liver Disease, including use
of antiviral, will be given to all patients.
- Effort will be made to avoid use of other hepatotoxic drug(s) during Anti-Tubercular
Treatment.
- Liver function tests (LFT) will be done weekly during first 2 months then at one month
interval or as when required.
- The treatment efficacy of Anti-Tubercular Treatment (ATT) will be made on the basis of
clinical, biochemical, microbiological and imaging parameters at months 2, 4, 7 and 9.
Patients not improving at 4 weeks after initiation of treatment will be shifted to
alternative regimens and will be excluded from the study.
| Status | Recruiting |
| Enrollment | 120 |
| Est. completion date | September 2014 |
| Est. primary completion date | September 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 75 Years |
| Eligibility |
Inclusion Criteria: - Males or Females subjects aged 18-75 years. - Subjects with chronic liver disease (cirrhosis) - Pulmonary or extra-pulmonary tuberculosis. - Serum ALT=5times upper limit and serum bilirubin =3 mg/dl. - consent and willingness to follow-up Exclusion Criteria: - Serum ALT>5times upper limit and serum bilirubin >3 mg/dl. - Renal failure (serum creatinine>2mg/dl). - Presence of hepatocellular carcinoma - Alcoholic cirrhotic who continue to drink alcohol. - Prior history of ATT (ANTI TUBERCULAR TREATMENT) with documented hepatotoxicity. - Known hypersensitivity to levofloxacin, other quinolones |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| India | Institute of Liver and Biliary Sciences | New Delhi | Delhi |
| Lead Sponsor | Collaborator |
|---|---|
| Institute of Liver and Biliary Sciences, India |
India,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Successful completion of modified ATT (ANTI TUBERCULAR TREATMENT) regimen. | 6 and 9 months | No | |
| Secondary | Worsening of CTP (CHILD TURCOTTE PUGH) score to =10 for patients with compensated cirrhosis, | 6 and 9 months | No | |
| Secondary | Failure to re-institute the assigned ATT (ANTI TUBERCULAR TREATMENT) regimen after development of an episode of hepatotoxicity. (I.e. second episode of hepatotoxicity. | No | ||
| Secondary | Survival | 6 and 9 months | No |