Çoklu Nükleos(t)id Analoğu Tedavisi Başarısız Olan Çin'deki Kronik Hepatit B Hastalarında Tenofovir Disoproksil Fumarat (TDF) 300 mg 3 Yıllık Çalışma

Sade dilde özet

Bu çalışma, daha önce birden fazla nükleos(t)id analoğu tedavisi başarısız olan Çin'deki kronik hepatit B (chronic hepatitis B) hastalarında Tenofovir Disoproksil Fumarat (TDF) 300 mg ilacını 3 yıl boyunca inceliyor. 18-65 yaş arası kronik hepatit B hastaları dahil edilmiştir. Faz 4 aşamasında yürütülmüş ve tamamlanmıştır.

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

Faz 4 (Phase 4)

Durum

Tamamlandı

Sponsor

GlaxoSmithKline

Müdahale

Tenofovir disoproxil fumarate

Başlangıç

18.03.2015

Tahmini bitiş

14.08.2018

Ülkeler

China

İlgili genler

Merkezler

• Guangzhou, China
• Guangzhou, China
• Changchun, China
• Chengdu, China
• Hangzhou, China
• Beijing, China
• Beijing, China
• Beijing, China
• Beijing, China
• Shanghai, China
• Shanghai, China
• Zhengzhou, China

Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

Inclusion Criteria:

* Aged between 18-65years (inclusive). Male or female; a female is eligible to enter and participate in this study if she is of: Non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal); or,
* Child-bearing potential, has a negative serum pregnancy test at baseline, and agrees to one of the following methods for avoidance of pregnancy during the period of the study and until 30 days after last dose of study medication: Oral contraceptive, either combined or progestogen alone, Injectable progestogen, Implants of levonorgestrel, Oestrogenic vaginal ring, Percutaneous contraceptive patches., Intrauterine device (IUD) or intrauterine system (IUS) showing that the expected failure rate is less than 1% per year as stated in the IUD or IUS product label, Has a male partner who is sterilised, Double barrier method: condom and an occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent (foam/gel/film /cream/suppository).
* The ability to understand and sign a written informed consent prior to any study-related procedure and comply with the requirements of the study.
* Positive HBsAg for more than 6 months, and anti-HBs negative.
* Serum HBV DNA level \>=200 IU/mL at study screening (Use central lab results).
* Experienced multiple NAs treatment failure which is defined as HBV DNA greater than 200 IU/mL after at least two NAs treatment (at least 6 months continuous treatment for each NA(s), total duration is no less than 12 months). In addition, subjects judged by the treating physician to have adhered to previous NA therapy.
* Agreement not to participate in any other investigational trials or to undertake other HBV systemic antiviral or interferon (IFN) regimens during participation in this study.

Exclusion Criteria:

* Hepatocellular carcinoma as evidenced by one of the following: Suspicious foci on ultrasound or radiological examination, Normal ultrasound but a history of rising serum alpha-fetoprotein and serum alpha-fetoprotein \>20 nanogram (ng) per mL at screening.
* Clinical signs of decompensated liver disease at baseline. These may include but are not limited to:Total serum bilirubin \>1.5 x Upper limit of the normal range (ULN), International Normalized Ratio \>1.3, Serum albumin \<32grams per Liter (g/L), History of clinical hepatic decompensation (e.g., ascites, variceal bleeding, or encephalopathy).
* Creatinine clearance less than 70 milliliter per minutes (mL/min).
* Alanine aminotransferase \>10 times ULN at screening or history of acute exacerbation leading to transient decompensation.
* Haemoglobin \<8 grams per deciliter (g/dL), absolute neutrophil count \<1.0 x 10\^9 per Liter, platelets \<75 x 10\^9 per Liter.
* Documented co-infection with hepatitis A (HAV), hepatitis C (HCV), hepatitis delta virus (HDV), hepatitis E virus (HEV) or Human immunodeficiency virus (HIV). For HCV co-infection, subjects who are anti-HCV positive and in whom HCV RNA is undetectable are considered to be not eligible for enrolment.
* Evidence of active liver disease due to autoimmune hepatitis (antinuclear antibody titre \>1:160)
* Any serious or active medical or psychiatric illnesses other than hepatitis B which, in the opinion of the Investigator, would interfere with subject treatment, assessment or compliance with the protocol. This would include any uncontrolled clinically significant renal, cardiac, pulmonary, vascular, neurogenic, digestive, metabolic (diabetes, thyroid disorders, adrenal disease), immunodeficiency disorders, pathological fractures or cancer.
* Active alcohol or drug abuse or history of alcohol or drug abuse considered by the Investigator to be sufficient to hinder compliance with treatment, participation in the study or interpretation of results.
* A female who is breastfeeding or plan to breast.
* Use of immunosuppressive therapy, immunomodulatory therapy \[including Pegylated interferon (PEG-IFN) and short-acting interferon or thymosin alpha\], systemic cytotoxic agents within the previous 6 months prior to screening.
* Planned for liver transplantation or previous liver transplantation.
* Receipt of TDF within 6 months prior to screening.
* Therapy with nephrotoxic drugs (e.g., aminoglycosides, amphotercin B, vancomycin, cidofovir, foscarnet, cis-platinum, pentamidine etc.) or competitors of renal excretion (e.g., probenecid) within 2 months prior to study screening or the expectation that subject will receive any of these during the course of the study.
* History of hypersensitivity to nucleoside and/or nucleotide analogues and/or any component of study medication.
* Inability to comply with study requirements as determined by the study Investigator.