Comparisons of the durability of 6 months versus 12 months antiviral therapy for hepatitis B after end of chemotherapy
| ISRCTN | ISRCTN17868223 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17868223 |
| Secondary identifying numbers | 104-7859C |
- Submission date
- 13/08/2021
- Registration date
- 13/10/2021
- Last edited
- 30/12/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English Summary
Background and study aims
Using chemotherapy to treat cancer has the side effect of a reduction in the body's ability to fight infection (immunosuppression). It is possible to provide some prevention of infection by giving antiviral drugs (prophylaxis antiviral therapy).
Prophylactic antiviral therapy is recommended for hepatitis B patients receiving chemotherapy but the ideal treatment duration after cessation chemotherapy lakes clinical evidence. We compare the relapse rate of 6 months and 12 months nucleoside analogues (NA) therapy in patients stratified by low HBV-DNA<2000 IU/ml or high HBV-DNA≥2000 IU/ml.
Who can participate?
Cancer patients with chronic hepatitis B receiving chemotherapy.
What does the study involve?
Participants received tenofovir or entecavir one week before chemotherapy. Following the end of chemotherapy, they were randomly allocated to receive 6 months or 12 months of NA therapy either low HBV-DNA<2000 IU/ml or high HBV-DNA≥2000 IU/ml.
What are the possible benefits and risks of participating?
Participants may benefit from tenofovir or entecavir treatment in patients with chronic hepatitis B during chemotherapy.
No definite risks known as current treatment duration is still unclear (6 or 12 months are suggested by different guidelines)
Where is the study run from?
Kaohsiung Chang Gung Memorial Hospital (Taiwan)
When is the study starting and how long is it expected to run for?
September 2012 to August 2017
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Tsung-Hui Hu, dr.hu@msa.hinet.net
Contact information
Scientific
123 Ta-Pei Road
Niao Sung District
Kaohsiung
833
Taiwan
 ORCID ID |
0000-0002-9172-1967 |
|---|---|
| Phone | +886-7-7317123 Ext. 8301 |
| dr.hu@msa.hinet.net |
Study information
| Study design | Open level randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | A prospective single-center, open-level, randomized study to compare the effectiveness of extended 6 versus 12 months tenofovir or entecavir therapy between HBV patients with cancer after completion of immunosuppressive anticancer therapy |
| Study hypothesis | Prophylactic antiviral therapy is recommended for hepatitis B patients receiving chemotherapy but the ideal treatment duration after cessation of chemotherapy lacks clinical evidence. |
| Ethics approval(s) | Approved 02/11/2015, Ethics Committee of Chang Gung Memorial Hospital (No 199, Dunhua N Rd. Songshan Dist. Taipei City, Taiwan; violet1202@cgmh.org.tw; +886-3-3196200 ext 3717), ref: 104-7859C |
| Condition | Hepatitis B in patients with cancer after completion of immunosuppressive anticancer therapy |
| Intervention | This was a randomized, open-label study in NA-naïve HBeAg-positive and HBeAg-negative patients with CHB. Patients received Tenofovir 300mg or Entecavir 0.5mg one week before chemotherapy and were randomized into 4 groups (using an online tool) after cessation chemotherapy: HBV DNA <2000 IU/ml, 6-month or 12-month duration HBV DNA ≥2000 IU/ml, 6-month or 12-month duration |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Tenofovir disoproxil fumarate, entecavir |
| Primary outcome measure | Virological relapse and clinical relapse rate measured using patient records at baseline, 3, 6, 9 and 12 months after cessation of antiviral therapy |
| Secondary outcome measures | 1. Presence of HBsAg, HBeAg and Anti-HBe determined by commercial assays (Abbott, North Chicago, IL., USA) at baseline, 3, 6, 9 and 12 months after cessation of antiviral therapy, and then after every 6 months 2. Serum HBV DNA levels were assessed using COBAS AmpliPrep-COBAS Taqman HBV test (Roche Molecular System, Inc., Branchburg, NJ, USA), with a lower detection limit of 20IU/ml at baseline, 3, 6, 9 and 12 months after cessation of antiviral therapy, and then after every 6 months |
| Overall study start date | 04/09/2012 |
| Overall study end date | 22/08/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 72 |
| Total final enrolment | 61 |
| Participant inclusion criteria | 1. Over 20 years old 2. Hepatitis B surface antigen (HBsAg) seropositive for >6 months 3. Cancer patients receiving chemotherapy |
| Participant exclusion criteria | Patients who had co-infection with human immunodeficiency virus, hepatitis C virus or hepatitis D virus by serological assays |
| Recruitment start date | 01/01/2013 |
| Recruitment end date | 31/12/2016 |
Locations
Countries of recruitment
- Taiwan
Study participating centre
Kaohsiung
833
Taiwan
Sponsor information
Hospital/treatment centre
123 Ta-Pei Road
Niao Sung District
Kaohsiung
833
Taiwan
| Phone | +886-7-7317123 |
|---|---|
| ccyi@cgmh.org.tw | |
| Website | https://www1.cgmh.org.tw/branch/shk/index.htm |
"ROR" |
https://ror.org/00k194y12 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/09/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 30/12/2021 | No | No |
Additional files
Editorial Notes
30/12/2021: Sponsor email address updated.
13/10/2021: Internal review.
12/10/2021: Trial's existence confirmed by Ethics Committee of Chang Gung Memorial Hospital.
