Adefovir and Lamivudine for Entecavir Resistance (ALTER Study)
NCT ID: NCT01546116
Last Updated: 2014-02-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
20 participants
INTERVENTIONAL
2010-02-28
2014-02-28
Brief Summary
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* In case of entecavir resistance, adefovir could be used. However, sequential monotherapy may result in multidrug resistance.
* It is thought that adefovir and lamivudine combination therapy reduce the risk of adefovir resistance, thereby continued therapy will lead to suppression of hepatitis B virus (HBV) DNA to be undetectable in patients with entecavir resistance.
* This study aim to evaluate the efficacy of adefovir and lamivudine combination therapy in CHB patients with entecavir resistance.
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Detailed Description
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The aim of this study is to evaluate the efficacy of adefovir and lamivudine combination therapy in CHB patients with entecavir resistance.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Adefovir and lamivudine combination
ADEFOVIR, LAMIVUDINE
Adefovir/10mg tablet/once a day/52week Lamivudine/100mg tablet/once a day/52week
Interventions
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ADEFOVIR, LAMIVUDINE
Adefovir/10mg tablet/once a day/52week Lamivudine/100mg tablet/once a day/52week
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age \> 18 year old
3. History of treatment with entecavir more than 6 months
4. Proven entecavir resistant mutation (rtT184S/A/I/L/G/C/M, rtS202G/C/I, or rtM250I/V)
5. HBV DNA level\> 2000 IU/mL
6. Compensated liver disease (Child-Pugh-Turcotte score over 7; prothrombin time prolonged more than 3 sec above ULN or INR over 1.5; serum albumin \>3 g/dL; total bilirubin \<2.5 mg/dL; No history of variceal bleeding, ascites, or hepatic encephalopathy)
7. Patients willing to give informed consent
2. Any one of following
* Serum phosphorus level under 2.4 mg/dL
* Serum creatinine level over 1.5 mg/dL or creatinine clearance \<50 mL/min
* Absolute neutrophil count lower than 1000 cell/mL
* Hb level under 10 g/dL (male), under 9 g/dL (female)
* Serum AFP \>100 ng/mL
3. History of treatment with interferon-alfa, thymosin-alfa 1, or nucleos(t)ide analogue other than entecavir in 6 months of screening
4. History of adefovir resistance (detection of rtA181T/Vor rtN236T at screening or in the past)
5. Recipient of organ transplantation
6. Positive antibody test to HIV, HCV or HDV
7. Pregnant or breast feeding women
8. Patients with hepatocellular carcinoma or uncontrolled malignant disease
9. Habitual alcohol drinker (\>140 g/week for men, \>70 g/week for women) -
18 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Korea University
OTHER
Responsible Party
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Hyung Joon Yim
Associate Professor
Principal Investigators
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HYUNG JOON YIM, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Korea University Ansan Hospital
Locations
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Chungbuk National University Hospital
Cheongju-si, Chngcheongbuk-do, South Korea
Yonsei University Wonju Christian Hospital
Wŏnju, Gangwon-do, South Korea
Korea University Ansan Hospital
Ansan, Gyeonggi-do, South Korea
Hallym University, Sacred Heart Hospital
Anyang-si, Gyeonggi-do, South Korea
The Catholic University of Korea, Euijeongbu Saint Mary's Hospital
Euijeongbu, Gyeonggi-do, South Korea
Gachon University Gil Medical Center
Incheon, , South Korea
Inha University Hospital
Incheon, , South Korea
Hallym University, Gangnam Sacred Heart Hospital
Seoul, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Countries
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References
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Lee WM. Hepatitis B virus infection. N Engl J Med. 1997 Dec 11;337(24):1733-45. doi: 10.1056/NEJM199712113372406. No abstract available.
Lok AS, McMahon BJ. Chronic hepatitis B: update 2009. Hepatology. 2009 Sep;50(3):661-2. doi: 10.1002/hep.23190. No abstract available.
Tenney DJ, Rose RE, Baldick CJ, Pokornowski KA, Eggers BJ, Fang J, Wichroski MJ, Xu D, Yang J, Wilber RB, Colonno RJ. Long-term monitoring shows hepatitis B virus resistance to entecavir in nucleoside-naive patients is rare through 5 years of therapy. Hepatology. 2009 May;49(5):1503-14. doi: 10.1002/hep.22841.
Yim HJ, Hussain M, Liu Y, Wong SN, Fung SK, Lok AS. Evolution of multi-drug resistant hepatitis B virus during sequential therapy. Hepatology. 2006 Sep;44(3):703-12. doi: 10.1002/hep.21290.
Lampertico P, Vigano M, Manenti E, Iavarone M, Sablon E, Colombo M. Low resistance to adefovir combined with lamivudine: a 3-year study of 145 lamivudine-resistant hepatitis B patients. Gastroenterology. 2007 Nov;133(5):1445-51. doi: 10.1053/j.gastro.2007.08.079. Epub 2007 Sep 2.
Rapti I, Dimou E, Mitsoula P, Hadziyannis SJ. Adding-on versus switching-to adefovir therapy in lamivudine-resistant HBeAg-negative chronic hepatitis B. Hepatology. 2007 Feb;45(2):307-13. doi: 10.1002/hep.21534.
Villet S, Ollivet A, Pichoud C, Barraud L, Villeneuve JP, Trepo C, Zoulim F. Stepwise process for the development of entecavir resistance in a chronic hepatitis B virus infected patient. J Hepatol. 2007 Mar;46(3):531-8. doi: 10.1016/j.jhep.2006.11.016. Epub 2006 Dec 18.
Yatsuji H, Hiraga N, Mori N, Hatakeyama T, Tsuge M, Imamura M, Takahashi S, Fujimoto Y, Ochi H, Abe H, Maekawa T, Suzuki F, Kumada H, Chayama K. Successful treatment of an entecavir-resistant hepatitis B virus variant. J Med Virol. 2007 Dec;79(12):1811-7. doi: 10.1002/jmv.20981.
Other Identifiers
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ALTER_114093
Identifier Type: -
Identifier Source: org_study_id
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