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Multicenter, Randomized, Placebo-Controlled, Double-blind Phase 2 Study to Evaluate the Short-term Efficacy, Safety and Tolerance and to Find an Optimal Dosage of the PENNEL Capsule for the Patients With Chronic Liver Disease


Phase 2
20 Years
65 Years
Not Enrolling
Both
Chronic Liver Disease

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Trial Information

Multicenter, Randomized, Placebo-Controlled, Double-blind Phase 2 Study to Evaluate the Short-term Efficacy, Safety and Tolerance and to Find an Optimal Dosage of the PENNEL Capsule for the Patients With Chronic Liver Disease


Inclusion Criteria:



- Patients with chronic liver disease.

- Patients over 20, under 65 years of age.

- Patients with abnormal transaminase levels.

Exclusion Criteria:

- Pregnant and lactating women.

- Patients who have any history of esophageal bleeding, hepatic encephalopathy,
ascites.

- Diabetes, thyroid dysfunction, fatty liver, liver cancer patients.

- Toxic hepatitis, alcoholic hepatitis.

- Total bilirubin value more than 3.0 mg/dl.

- Albumin value less than 3.0 g/dl.

- Patients who participating in other study about drug.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

ALT (Alanine Aminotransferase)

Outcome Description:

To evaluate the efficacy of the PENNEL capsule on change ALT from baseline to 6 weeks (Change from Baseline in Alanine Aminotransferase at 6 weeks) The measurements were conducted five times, including ① before administration, ② the 1st week of administration, ③ the 3rd week of administration, ④ the 6th week of administration, and ⑤ the 1st week after the six-week administration.

Outcome Time Frame:

6 week

Safety Issue:

No

Principal Investigator

Minho Lee, MD.PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hanyang University

Authority:

Korea: Food and Drug Administration

Study ID:

PMK-PENNEL 2

NCT ID:

NCT01393665

Start Date:

December 1996

Completion Date:

October 1997

Related Keywords:

  • Chronic Liver Disease
  • Liver Diseases

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