Efficacy and safety of Entecavir plus Carnitine complex compared with entecavir monotherapy in patients with chronic hepatitis B.

Efficacy and safety of Entecavir plus Carnitine complex (Godex(TM)) compared with Entecavir monotherapy in patients with ALT elevated chronic hepatitis B; Randonmized, Multicenter Open-label trial.

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0000084

Enrollment

130

Registered

2011-01-24

Start date

2010-11-30

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Generic/Brand name: Carnitine Orotate ect. / Godex(TM), 412mg/1cap, 2caps p.o. t.i.d.(2,472mg/day) Generic/Brand name: Entecavir / Baraclude(TM), 0.5mg/1tab, 1tab p.o. q.d.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Chronic Hepatitis B patients - 80U/L = ALT = 10 X ULN - HBeAg positive(HBV DNA > 100,000 copies/ml) or HBeAg negative(HBV DNA > 10,000 copies/ml) - Never received antiviral treatment for Hepatitis B or had antiviral treatment duration of less than 3 months at least one year prior to study entry.

Exclusion criteria

Exclusion criteria: - The patient with HAV IgM Ab positive or HCV-RNA positive or HCV Ab positive - History of hepatic coma or esophageal varices or spontaneous bacterial peritonitis or decompensated liver cirrhosis with Child-Pugh score > 10 - Presence of liver cancer or other malignant tumor - Medical history or condition associated with chronic liver disease.

Design outcomes

Primary

Measure	Time frame
The rate of ALT normalization	—

Secondary

Measure	Time frame
The rate of combined ALT normalization and HBV DNA < 300 copies/ml;The rate of serum HBV DNA < 300 copies/ml;The changes of HBV DNA titer;The changes of HBs Ag titer;The changes of Lymphocyte activity (INF-gamma);The changes of Peripheral blood mitochondrial DNA copy number	—

Countries

Korea, Republic of

Contacts

Public ContactDae-won Jun

Hanyang University Seoul Hospital

Outcome results