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Lactic Acidosis During Entecavir(ETV)Treatment (ETV)

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ClinicalTrials.gov Identifier: NCT01354652
Recruitment Status : Terminated (Tenofovir has become available in Korea.)
First Posted : May 17, 2011
Results First Posted : February 20, 2015
Last Update Posted : May 9, 2018
Sponsor:
Information provided by (Responsible Party):
Han Chu Lee, Asan Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Lactic Acidosis
Intervention Drug: entecavir, lamivudine
Enrollment 5
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Entecavir Lamivudine no NRTI Group
Hide Arm/Group Description

Oral 0.5mg/day until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18.

Participants will be followed for the duration of hospital stay, an expected average of 8 weeks.

entecavir, lamivudine: entecavir: 0.5mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.

lamivudine: 100mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.

Oral 100mg/day lamivudine until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18.

Participants will be followed for the duration of hospital stay, an expected average of 8 weeks.

entecavir, lamivudine: entecavir: 0.5mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.

lamivudine: 100mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.

hepatitis C virus associated LC patients for the calculation of lactic acidosis incidence
Period Title: Overall Study
Started 3 2 0
Completed 0 0 0
Not Completed 3 2 0
Arm/Group Title Entecavir Lamivudine no NRTI Group Total
Hide Arm/Group Description

Oral 0.5mg/day until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18.

Participants will be followed for the duration of hospital stay, an expected average of 8 weeks.

entecavir, lamivudine: entecavir: 0.5mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.

lamivudine: 100mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.

Oral 100mg/day lamivudine until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18.

Participants will be followed for the duration of hospital stay, an expected average of 8 weeks.

entecavir, lamivudine: entecavir: 0.5mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.

lamivudine: 100mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.

hepatitis C virus associated LC patients for the calculation of lactic acidosis incidence Total of all reporting groups
Overall Number of Baseline Participants 3 2 0 5
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 2 participants 0 participants 5 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
3
 100.0%
2
 100.0%
5
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants 2 participants 0 participants 5 participants
52.3  (6.8) 38.0  (7.1) 46.6  (9.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 2 participants 0 participants 5 participants
Female
1
  33.3%
0
   0.0%
1
  20.0%
Male
2
  66.7%
2
 100.0%
4
  80.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 2 participants 0 participants 5 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
3
 100.0%
2
 100.0%
5
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 2 participants 0 participants 5 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
3
 100.0%
2
 100.0%
5
 100.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Korea, Republic of Number Analyzed 3 participants 2 participants 0 participants 5 participants
3 2 5
1.Primary Outcome
Title Incidence of Elevated Venous Lactate Levels More Than 2 mmol/L of Any Etiology
Hide Description incidence of elevated venous lactate levels more than 2 mmol/L of any etiology until development of lactic acidosis, orthotropic liver transplantation (OLT), death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.
Time Frame participants will be followed for the duration of hospital stay, an expected average of 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Our study was terminated early with only 5 participant enrolled. We gained lactic acid levels for the 5 patients (all elevated), however we considered that it was not sufficient to be analyzed. Morover, we did not further investigate the etiology for elevated lactic acid levels and secondary etiology-based outcomes are not recorded here.
Arm/Group Title Entecavir Lamivudine no NRTI Group
Hide Arm/Group Description:

Oral 0.5mg/day until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18.

Participants will be followed for the duration of hospital stay, an expected average of 8 weeks.

entecavir, lamivudine: entecavir: 0.5mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.

lamivudine: 100mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.

Oral 100mg/day lamivudine until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18.

Participants will be followed for the duration of hospital stay, an expected average of 8 weeks.

entecavir, lamivudine: entecavir: 0.5mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.

lamivudine: 100mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.

hepatitis C virus associated LC patients for the calculation of lactic acidosis incidence
Overall Number of Participants Analyzed 3 2 0
Measure Type: Number
Unit of Measure: participants
3 2
2.Secondary Outcome
Title Incidence of Elevated Venous Lactate Levels More Than 2 mmol/L Directly Related to NRTI
Hide Description incidence of elevated venous lactate levels more than 2 mmol/L directly related to NRTI until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.
Time Frame Participants will be followed for the duration of hospital stay, an expected average of 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Secondary outcome assessment was not performed due to early termination of the study.
Arm/Group Title Entecavir Lamivudine no NRTI Group
Hide Arm/Group Description:

Oral 0.5mg/day until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18.

Participants will be followed for the duration of hospital stay, an expected average of 8 weeks.

entecavir, lamivudine: entecavir: 0.5mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.

lamivudine: 100mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.

Oral 100mg/day lamivudine until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18.

Participants will be followed for the duration of hospital stay, an expected average of 8 weeks.

less than 18 and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.

entecavir, lamivudine: entecavir: 0.5mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score lamivudine: 100mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.

hepatitis C virus associated LC patients for the calculation of lactic acidosis incidence
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Incidence of Elevated Venous Lactate Levels More Than 2 mmol/L Caused by Etiologies Other Than NTRIs
Hide Description incidence of elevated venous lactate levels more than 2 mmol/L caused by etiologies other than NTRIs until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.
Time Frame Participants will be followed for the duration of hospital stay, an expected average of 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Secondary outcome assessment was not performed due to early termination of the study.
Arm/Group Title Entecavir Lamivudine no NRTI Group
Hide Arm/Group Description:

Oral 0.5mg/day until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18.

Participants will be followed for the duration of hospital stay, an expected average of 8 weeks.

entecavir, lamivudine: entecavir: 0.5mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.

lamivudine: 100mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.

Oral 100mg/day lamivudine until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18.

Participants will be followed for the duration of hospital stay, an expected average of 8 weeks.

entecavir, lamivudine: entecavir: 0.5mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.

lamivudine: 100mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.

hepatitis C virus associated LC patients for the calculation of lactic acidosis incidence
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Frequency of Concomitant Prescribed Medications Possibly Associated With Lactic Acidosis Other Than NTRIs
Hide Description Frequency of concomitant prescribed medications possibly associated with lactic acidosis other than NTRIs until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.
Time Frame Participants will be followed for the duration of hospital stay, an expected average of 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Secondary outcome assessment was not performed due to early termination of the study.
Arm/Group Title Entecavir Lamivudine no NRTI Group
Hide Arm/Group Description:

Oral 0.5mg/day until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18.

Participants will be followed for the duration of hospital stay, an expected average of 8 weeks.

entecavir, lamivudine: entecavir: 0.5mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.

lamivudine: 100mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.

Oral 100mg/day lamivudine until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18.

Participants will be followed for the duration of hospital stay, an expected average of 8 weeks.

less than 18 and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.

entecavir, lamivudine: entecavir: 0.5mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score lamivudine: 100mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.

hepatitis C virus associated LC patients for the calculation of lactic acidosis incidence
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Arterial pH and Anion Gap in Cases With Elevated Blood Lactate Levels (at the Time of Detection and Peak Levels
Hide Description Arterial pH and anion gap in cases with elevated blood lactate levels (at the time of detection and peak levels until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.
Time Frame Participants will be followed for the duration of hospital stay, an expected average of 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Secondary outcome assessment was not performed due to early termination of the study.
Arm/Group Title Entecavir Lamivudine no NRTI Group
Hide Arm/Group Description:

Oral 0.5mg/day until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18.

Participants will be followed for the duration of hospital stay, an expected average of 8 weeks.

entecavir, lamivudine: entecavir: 0.5mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.

lamivudine: 100mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.

Oral 100mg/day lamivudine until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18.

Participants will be followed for the duration of hospital stay, an expected average of 8 weeks.

entecavir, lamivudine: entecavir: 0.5mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.

lamivudine: 100mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.

hepatitis C virus associated LC patients for the calculation of lactic acidosis incidence
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Overall OLT-free Survival
Hide Description Overall OLT-free survival until development of OLT and death and participants will be followed for the duration of hospital stay or outpatients visit, an expected average of 12 months
Time Frame Participants will be followed for the duration of hospital stay or outpatients visit, an expected average of 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Entecavir Lamivudine no NRTI Group
Hide Arm/Group Description:

Oral 0.5mg/day until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18.

Participants will be followed for the duration of hospital stay, an expected average of 8 weeks.

entecavir, lamivudine: entecavir: 0.5mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.

lamivudine: 100mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.

Oral 100mg/day lamivudine until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18.

Participants will be followed for the duration of hospital stay, an expected average of 8 weeks.

less than 18 and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.

entecavir, lamivudine: entecavir: 0.5mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score lamivudine: 100mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.

hepatitis C virus associated LC patients for the calculation of lactic acidosis incidence
Overall Number of Participants Analyzed 3 2 0
Mean (Standard Deviation)
Unit of Measure: day
411  (311) 175  (223)
Time Frame at least every week during hospital day upto 2 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Entecavir Lamivudine no NRTI Group
Hide Arm/Group Description

Oral 0.5mg/day until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18.

Participants will be followed for the duration of hospital stay, an expected average of 8 weeks.

entecavir, lamivudine: entecavir: 0.5mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.

lamivudine: 100mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.

Oral 100mg/day lamivudine until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18.

Participants will be followed for the duration of hospital stay, an expected average of 8 weeks.

entecavir, lamivudine: entecavir: 0.5mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.

lamivudine: 100mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.

hepatitis C virus associated LC patients for the calculation of lactic acidosis incidence
All-Cause Mortality
Entecavir Lamivudine no NRTI Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)   0/2 (0.00%)   0/0 
Show Serious Adverse Events Hide Serious Adverse Events
Entecavir Lamivudine no NRTI Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)   0/2 (0.00%)   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Entecavir Lamivudine no NRTI Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)   0/2 (0.00%)   0/0 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Han Chu Lee
Organization: AsanMC
Phone: 82230103915
EMail: hch@amc.seoul.kr
Layout table for additonal information
Responsible Party: Han Chu Lee, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01354652     History of Changes
Other Study ID Numbers: Hanchu3915
First Submitted: May 11, 2011
First Posted: May 17, 2011
Results First Submitted: January 18, 2015
Results First Posted: February 20, 2015
Last Update Posted: May 9, 2018