NCT01715987

Tubular Function in Asian-American Patients Receiving TDF or ETV for HBV Treatment

A Prospective and Open-Label Study of the Effect on Proximal Tubular Function in Asian-American Patients Receiving Tenofovir Disoproxil Fumarate (TDF) or Entecavir (ETV) for HBV Treatment

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 48 (actual)
• Sponsor: New Discovery LLC · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Nucleotide anti-viral analogues, including adefovir and TDF, have demonstrated kidney toxicity in HIV/HBV co-infected patients and HBV mono-infected European patients. Investigators suspected similar kidney proximal tubular injury can also occur in HBV mono infected Asian patients receiving TDF treatment.

Detailed description

The primary objective of this study is to evaluate the safety use of ETV and TDF after at least 144 weeks of treatment in terms of the effects of renal tubular function as determined by (1) 24 hours Urine phosphate (wasting is \>1200 mg daily); (2) 24 hours β2-microglobulinuria (NL β2-microglobulin level, \<1 mg daily); (3) fractional excretion of uric acid, and (4) fractional tubular reabsorption of phosphorus. The secondary objectives are to evaluate: 1. To evaluate compare the anti-viral effects of both TDF and ETV as determined the percentage of patient who achieve HBV DNA levels below 60 IU/mL (by quantitative HBV DNA PCR test with lowest level of detection at 60 IU/mL) and ALT normalization by routine biochemical test after 144 weeks of treatment. 2. Serological responses including percentage of patients with HBeAg loss or seroconversion and HBsAg loss or seroconversion with TDF and ETV treatment in Asian-American adults with CHB infection. 3. To evaluate the three-year (one year treatment before enrollment and two year treatment after enrollment) the percentage of patient with anti-HBV drug resistance of TDF and ETV, including genotypic mutations in Asian-American adults with CHB.

Conditions

• Hepatitis B

Interventions

Type	Name	Description
DRUG	Tenofovir Disoproxil Fumarate	300mg, oral daily for two years
DRUG	Entecavir	0.5mg oral daily for two years.

Timeline

• Start date: 2012-10-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2012-10-29
• Last updated: 2017-09-06

Locations

2 sites across 1 country: United States