Hepatitis DPhase 2HIDIT-IINCT00932971
HIDIT II - PegIFN-alfa2a Plus Tenofovir in Chronic Delta Hepatitis
A Phase 2 study testing PEG-IFN alfa-2a, Tenofovir in people with Hepatitis D, run by HepNet Study House, German Liverfoundation at 10 sites in 3 countries.
Trial summary
Randomized, double blind study comparing the efficacy of pegylated interferon-alfa2a plus placebo versus pegylated interferon-alfa2a plus tenofovir for the treatment of chronic delta hepatitis. 70 Patients will be randomized 1:1 into the two groups. Treatment duration: 96 weeks. Follow-up: 24 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis D
- What is being tested?
- PEG-IFN alfa-2a, Tenofovir
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 10 sitesin 3 countries
- Study dates
- Jun 2009to 2 Aug 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent.
- Age > 18 years.
- Positive HBsAg, for at least the prior 6 months, positive anti-HDV for at least 3 months and positive for HDV-RNA by PCR within the screening period.
- Elevated serum ALT ≥ ULN but ≤ 10X ULN as determined by two abnormal values taken > 1 month apart during the 12 months before the first dose of study drug with at least one of the determinations obtained ≤ 35 days prior to the first dose.
- A liver biopsy obtained within the past 12 months demonstrating liver disease consistent with chronic hepatitis. Patients with cirrhosis on liver biopsy must also have a liver imaging investigation to rule out hepatic carcinoma.
- Negative urine or serum pregnancy test documented within the 24 hour period prior to the first dose of test drug.
- Additionally, all fertile males with partners of childbearing age and females should use two reliable forms of effective contraception (combined) throughout the entire period of the study (treatment and for 4 months after treatment completion)
- Creatinine clearance ≥ 70 mL/min
Who cannot join
- Patients must not have received antiviral therapy for their chronic hepatitis D within the previous 6 months. Patients who are expected to need systemic antiviral therapy other than that provided by the study at any time during their participation in the study are also excluded.
- Positive test at screening for HAV-Ag-IgM, HCV-RNA or HCV-Ag or HIV-Ag.
- Serum concentrations of ceruloplasmin or alpha-1-antitrypsin consistent with an increased risk of metabolic liver disease.
- Evidence of decompensated liver disease (Childs B-C).
- History or other evidence of a medical condition associated with chronic liver disease (e.g., hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposures, thalassemia).
- Women with ongoing pregnancy or who are breast feeding.
Show all 23Show fewer
- WBC count of < 3.000 cells/ mm3; neutrophil count < 1.500 cells/mm3or platelet count < 90.000 cells/mm3.
- Evidence of alcohol and/or drug abuse within one year of entry.
- Patients are excluded if any history of psychiatric disease, especially depression, or of suicidal attempts is evident.
- History of immunologically mediated disease.
- History or other evidence of decompensated liver disease.
- History or other evidence of chronic pulmonary disease associated with functional limitation.
- History of severe cardiac disease
- Evidence of an active or suspected cancer or a history of malignancy where there is a risk of cancer to recur.
- History of having received any systemic anti-neoplastic (including radiation) or immunomodulatory treatment (including systemic corticosteroids) ≤ 6 months prior to the first dose of study drug or the expectation that such treatment will be needed at any time during the study.
- History of any organ transplantation with an existing functional graft
- History of thyroid disease poorly controlled on prescribed medications. Patients with elevated thyroid stimulating hormone concentrations with elevation of antibodies to thyroid peroxidase and any clinical manifestations of thyroid disease are excluded.
- History or evidence of severe retinopathy or clinically relevant ophthalmological disorder.
- Inability or unwillingness to provide informed consent or abide by the requirements of the study.
- History or other evidence of severe illness or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study.
- Patients with a value of alpha-fetoprotein >100 ng/mL are excluded, unless stability (less than 10% increase) has been documented over at least the previous 3 months.
- History or evidence for any intolerance or hypersensitivity to pegylated interferon-alfa-2a, tenofovir or other substances part of the study medication.
- Current participation in any other investigational trial and participation in another investigational trial within 3 months before the trial begins.
Trial locations and contacts
10 sites in 3 countries.
10 sites in 3 countries
Germany7 sites
Charité Campus Virchow-Klinikum, Med. Klinik für Gastroenterologie und Hepatologie
Berlin, 13353
Friedrich-Wilhelms-Universität, Med. Klinik und Poliklinik I
Bonn, 53105
Universitätsklinikum Düsseldorf, Klinik für Gastroenterologie
Düsseldorf, 40225
Klinikum der J.W. Goethe-Universität
Frankfurt, 60590
Universitätsklinikum Hamburg-Eppendorf, Klinik für Innere Medizin
Hamburg, 20246
Medizinische Hochschule Hannover, Zentrum Innere Medizin
Hanover, 30625
Medizinische Fakultät der Universität Heidelberg, Innere Medizin IV
Heidelberg, 69120
Romania2 sites
Institutul de Boli Infectioase "Prof. Dr. Matei Bals"
Bucharest, 021105
Spitalul Clinic de Boli Infectioase si
Timișoara, 300312
Greece1 site
Athens University School of Medicine, Hippokration General Hospital
Athens, 11527
About this study
Official title: A Multicenter Randomised Study Comparing the Efficacy of PegIFN-alfa2a Plus Placebo vs. PegIFN-alfa2a Plus Tenofovir for the Treatment of Chronic Delta Hepatitis-The Hep-Net International Delta Hepatitis Interventional Trial II (HIDIT-II)
Randomized, double blind study comparing the efficacy of pegylated interferon-alfa2a plus placebo versus pegylated interferon-alfa2a plus tenofovir for the treatment of chronic delta hepatitis. 70 Patients will be randomized 1:1 into the two groups. Treatment duration: 96 weeks. Follow-up: 24 weeks. Long-term-follow-up: until week 358.
- Conditions
- Hepatitis D
- Being tested
- PEG-IFN alfa-2a, Tenofovir, PEG-IFN alfa-2a, placebo
- Medical subject headings
- Hepatitis D
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEG-IFN alfa-2a, TenofovirDrug
Also called Pegasys, Viread
Pegylated interferon alfa-2a, 180µg once weekly, subcutaneously; Tenofovir disoproxilfumarat, 245mg, once daily, orally
PEG-IFN alfa-2a, placeboDrug
Also called Pegasys
Pegylated interferon alfa-2a, 180µg once weekly, subcutaneously; Placebo, once daily, orally
| Study group | Role | What they receive |
|---|---|---|
| PEG-IFN alfa-2a plus placebo | Placebo comparator | Pegylated interferon alfa-2a 180 µg once weekly (QW) subcutaneous (sc) plus placebo once daily, orally Receives: Drug: PEG-IFN alfa-2a, placebo |
| PEG-IFN alfa-2a plus Tenofovir | Active comparator | Pegylated interferon alfa-2a 180 µg once weekly (QW) subcutaneous (sc) plus Tenofovir disoproxilfumarat 245mg once daily, orally Receives: Drug: PEG-IFN alfa-2a, Tenofovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Negativation of HDV-RNA at the end of therapy
Measured: week 96
Secondary outcomes (11)
Negativation of HDV-RNA at week 48 of treatment
Measured: week 48
Negativation of HDV-RNA 24 weeks after the end of treatment
Measured: week 120
Normalization of ALT levels at the end of treatment and at the end of follow-up
Measured: week 96 and week 356
HDV-RNA-levels over time
Measured: up to week 356
Suppression of HBV-DNA below 6 IU/ml using the Cobas TaqMan assay at treatment weeks 48 and 96 and 24 weeks after treatment
Measured: week 48, week 96, week 120
Liver histology at end of treatment (Ishak score for inflammation and fibrosis)
Measured: week 96
Quantitative HBsAg levels over time. Loss of HBsAg and development of anti-HBs antibodies, intrahepatic cccDNA and HBV-DNA levels over time
Measured: up to week 356
HBV- and HDV-virus-specific T cell responses during therapy and after 24 weeks of follow up if virological and biochemical efficacy has been shown
Measured: up week 120
Virological long-term outcome
Measured: 1, 2, 3, 4 and 5 years after the end of treatment
Clinical long-term outcome
Measured: 1, 2, 3, 4 and 5 years after the end of treatment
Quality of Life
Measured: up to week 356
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2009 (estimated)
- Study startJun 2009
- Primary completionAug 2017
- Study completion2 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Hepatitis DStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- HepNet Study House, German Liverfoundation
- Sponsor type
- Research network
- Collaborators
- Hannover Medical School, Hoffmann-La Roche, Gilead Sciences
- Responsible party
- Sponsor
- Investigators
- Michael P. Manns, Prof. Dr., Study director, Hannover Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00932971
- Sponsor's protocol ID
- Hep-Net-HIDIT-II
- Other IDs
- EudraCT-No.: 2008-005560-13
- Acronym
- HIDIT-II
- Status last verified
- Jan 2018
- First submitted
- 3 Jul 2009
- Last updated
- 29 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Heidrich B, Deterding K, Tillmann HL, Raupach R, Manns MP, Wedemeyer H. Virological and clinical characteristics of delta hepatitis in Central Europe. J Viral Hepat. 2009 Dec;16(12):883-94. doi: 10.1111/j.1365-2893.2009.01144.x. Epub 2009 Jun 28.
PubMed 19566789Wedemeyer H, Yurdaydin C, Dalekos GN, Erhardt A, Cakaloglu Y, Degertekin H, Gurel S, Zeuzem S, Zachou K, Bozkaya H, Koch A, Bock T, Dienes HP, Manns MP; HIDIT Study Group. Peginterferon plus adefovir versus either drug alone for hepatitis delta. N Engl J Med. 2011 Jan 27;364(4):322-31. doi: 10.1056/NEJMoa0912696.
PubMed 21268724Heidrich B, Yurdaydin C, Kabacam G, Ratsch BA, Zachou K, Bremer B, Dalekos GN, Erhardt A, Tabak F, Yalcin K, Gurel S, Zeuzem S, Cornberg M, Bock CT, Manns MP, Wedemeyer H; HIDIT-1 Study Group. Late HDV RNA relapse after peginterferon alpha-based therapy of chronic hepatitis delta. Hepatology. 2014 Jul;60(1):87-97. doi: 10.1002/hep.27102.
PubMed 24585488Yurdaydin C, Kahlhofer J, Caruntu FA, Yalcin K, Gurel S, Akarca US, Sprinzl K, Bock HH, Bockmann JH, Papatheodoridis GV, Merle U, Demir M, Hardtke S, Keskin O, Idilman R, Cornberg M, Wedemeyer H, Wranke A. Ten-Year Follow-Up After 96 Weeks Treatment With Peginterferon Plus Tenofovir in Hepatitis D (HIDIT-II): Improved Clinical Outcome After Combination Therapy. United European Gastroenterol J. 2026 Feb;14(1):e70153. doi: 10.1002/ueg2.70153. Epub 2025 Nov 29.
PubMed 41317314Hardtke S, Yurdaydin C, Caruntu FA, Curescu MG, Yalcin K, Akarca US, Gurel S, Zeuzem S, Erhardt A, Luth S, Papatheodoridis GV, Port K, Manns MP, Cornberg M, Kahlhofer J, Wedemeyer H. Frequency, Severity and Impact of Pegylated Interferon Alpha-Associated Flares in Hepatitis D Infection. J Viral Hepat. 2025 Apr;32(4):e70022. doi: 10.1111/jvh.70022.
PubMed 40087915Anastasiou OE, Caruntu FA, Curescu MG, Yalcin K, Akarca US, Gurel S, Zeuzem S, Erhardt A, Luth S, Papatheodoridis GV, Keskin O, Port K, Radu M, Celen MK, Idilman R, Heidrich B, Mederacke I, von der Leyen H, Kahlhofer J, von Karpowitz M, Hardtke S, Cornberg M, Yurdaydin C, Wedemeyer H. Five-year follow-up of 96 weeks peginterferon plus tenofovir disoproxil fumarate in hepatitis D. Liver Int. 2024 Jan;44(1):139-147. doi: 10.1111/liv.15745. Epub 2023 Oct 3.
PubMed 37787009Wedemeyer H, Yurdaydin C, Hardtke S, Caruntu FA, Curescu MG, Yalcin K, Akarca US, Gurel S, Zeuzem S, Erhardt A, Luth S, Papatheodoridis GV, Keskin O, Port K, Radu M, Celen MK, Idilman R, Weber K, Stift J, Wittkop U, Heidrich B, Mederacke I, von der Leyen H, Dienes HP, Cornberg M, Koch A, Manns MP; HIDIT-II study team. Peginterferon alfa-2a plus tenofovir disoproxil fumarate for hepatitis D (HIDIT-II): a randomised, placebo controlled, phase 2 trial. Lancet Infect Dis. 2019 Mar;19(3):275-286. doi: 10.1016/S1473-3099(18)30663-7.
PubMed 30833068Bremer B, Anastasiou OE, Ciesek S, Wedemeyer H. Automated nucleic acid isolation methods for HDV viral load quantification can lead to viral load underestimation. Antivir Ther. 2019;24(2):117-123. doi: 10.3851/IMP3281.
PubMed 30516520
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomised Study Comparing the Efficacy of PegIFN-alfa2a Plus Placebo vs. PegIFN-alfa2a Plus Tenofovir for the Treatment of Chronic Delta Hepatitis-The Hep-Net International Delta Hepatitis Interventional Trial II (HIDIT-II)
- ClinicalTrials.gov ID
- NCT00932971
- Acronym / sponsor ID
- HIDIT-II / Hep-Net-HIDIT-II
- Conditions
- Hepatitis D
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- HepNet Study House, German LiverfoundationResearch network
- Collaborators
- Hannover Medical School, Hoffmann-La Roche, Gilead Sciences
- Study start
- Jun 2009
- Primary completion
- Aug 2017 (actual)
- Study completion
- 2 Aug 2017 (actual)
- First posted
- 7 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized, double blind study comparing the efficacy of pegylated interferon-alfa2a plus placebo versus pegylated interferon-alfa2a plus tenofovir for the treatment of chronic delta hepatitis. 70 Patients will be randomized 1:1 into the two groups. Treatment duration: 96 weeks. Follow-up: 24 weeks. Long-term-follow-up: until week 358.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEG-IFN alfa-2a plus placebo | Placebo comparator | Drug: PEG-IFN alfa-2a, placeboPegylated interferon alfa-2a 180 µg once weekly (QW) subcutaneous (sc) plus placebo once daily, orally |
| PEG-IFN alfa-2a plus Tenofovir | Active comparator | Drug: PEG-IFN alfa-2a, TenofovirPegylated interferon alfa-2a 180 µg once weekly (QW) subcutaneous (sc) plus Tenofovir disoproxilfumarat 245mg once daily, orally |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Written informed consent.
- Age > 18 years.
- Positive HBsAg, for at least the prior 6 months, positive anti-HDV for at least 3 months and positive for HDV-RNA by PCR within the screening period.
- Elevated serum ALT ≥ ULN but ≤ 10X ULN as determined by two abnormal values taken > 1 month apart during the 12 months before the first dose of study drug with at least one of the determinations obtained ≤ 35 days prior to the first dose.
- A liver biopsy obtained within the past 12 months demonstrating liver disease consistent with chronic hepatitis. Patients with cirrhosis on liver biopsy must also have a liver imaging investigation to rule out hepatic carcinoma.
Key exclusion criteria (23 listed)
- Patients must not have received antiviral therapy for their chronic hepatitis D within the previous 6 months. Patients who are expected to need systemic antiviral therapy other than that provided by the study at any time during their participation in the study are also excluded.
- Positive test at screening for HAV-Ag-IgM, HCV-RNA or HCV-Ag or HIV-Ag.
- Serum concentrations of ceruloplasmin or alpha-1-antitrypsin consistent with an increased risk of metabolic liver disease.
- Evidence of decompensated liver disease (Childs B-C).
- History or other evidence of a medical condition associated with chronic liver disease (e.g., hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposures, thalassemia).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEG-IFN alfa-2a, TenofovirAlso: Pegasys, VireadPegylated interferon alfa-2a, 180µg once weekly, subcutaneously; Tenofovir disoproxilfumarat, 245mg, once daily, orally | Drug | PEG-IFN alfa-2a plus Tenofovir |
| PEG-IFN alfa-2a, placeboAlso: PegasysPegylated interferon alfa-2a, 180µg once weekly, subcutaneously; Placebo, once daily, orally | Drug | PEG-IFN alfa-2a plus placebo |
Primary outcome
Negativation of HDV-RNA at the end of therapy
Time frame: week 96
11 secondary outcomes
Negativation of HDV-RNA at week 48 of treatment
Time frame: week 48
Negativation of HDV-RNA 24 weeks after the end of treatment
Time frame: week 120
Normalization of ALT levels at the end of treatment and at the end of follow-up
Time frame: week 96 and week 356
HDV-RNA-levels over time
Time frame: up to week 356
Suppression of HBV-DNA below 6 IU/ml using the Cobas TaqMan assay at treatment weeks 48 and 96 and 24 weeks after treatment
Time frame: week 48, week 96, week 120
Liver histology at end of treatment (Ishak score for inflammation and fibrosis)
Time frame: week 96
Quantitative HBsAg levels over time. Loss of HBsAg and development of anti-HBs antibodies, intrahepatic cccDNA and HBV-DNA levels over time
Time frame: up to week 356
HBV- and HDV-virus-specific T cell responses during therapy and after 24 weeks of follow up if virological and biochemical efficacy has been shown
Time frame: up week 120
Virological long-term outcome
Time frame: 1, 2, 3, 4 and 5 years after the end of treatment
Clinical long-term outcome
Time frame: 1, 2, 3, 4 and 5 years after the end of treatment
Quality of Life
Time frame: up to week 356
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2018.
- Background: PubMed 19566789Heidrich B, Deterding K, Tillmann HL, Raupach R, Manns MP, Wedemeyer H. Virological and clinical characteristics of delta hepatitis in Central Europe. J Viral Hepat. 2009 Dec;16(12):883-94. doi: 10.1111/j.1365-2893.2009.01144.x. Epub 2009 Jun 28.
- Background: PubMed 21268724Wedemeyer H, Yurdaydin C, Dalekos GN, Erhardt A, Cakaloglu Y, Degertekin H, Gurel S, Zeuzem S, Zachou K, Bozkaya H, Koch A, Bock T, Dienes HP, Manns MP; HIDIT Study Group. Peginterferon plus adefovir versus either drug alone for hepatitis delta. N Engl J Med. 2011 Jan 27;364(4):322-31. doi: 10.1056/NEJMoa0912696.
- Background: PubMed 24585488Heidrich B, Yurdaydin C, Kabacam G, Ratsch BA, Zachou K, Bremer B, Dalekos GN, Erhardt A, Tabak F, Yalcin K, Gurel S, Zeuzem S, Cornberg M, Bock CT, Manns MP, Wedemeyer H; HIDIT-1 Study Group. Late HDV RNA relapse after peginterferon alpha-based therapy of chronic hepatitis delta. Hepatology. 2014 Jul;60(1):87-97. doi: 10.1002/hep.27102.
- Derived from this study: PubMed 41317314Yurdaydin C, Kahlhofer J, Caruntu FA, Yalcin K, Gurel S, Akarca US, Sprinzl K, Bock HH, Bockmann JH, Papatheodoridis GV, Merle U, Demir M, Hardtke S, Keskin O, Idilman R, Cornberg M, Wedemeyer H, Wranke A. Ten-Year Follow-Up After 96 Weeks Treatment With Peginterferon Plus Tenofovir in Hepatitis D (HIDIT-II): Improved Clinical Outcome After Combination Therapy. United European Gastroenterol J. 2026 Feb;14(1):e70153. doi: 10.1002/ueg2.70153. Epub 2025 Nov 29.
- Derived from this study: PubMed 40087915Hardtke S, Yurdaydin C, Caruntu FA, Curescu MG, Yalcin K, Akarca US, Gurel S, Zeuzem S, Erhardt A, Luth S, Papatheodoridis GV, Port K, Manns MP, Cornberg M, Kahlhofer J, Wedemeyer H. Frequency, Severity and Impact of Pegylated Interferon Alpha-Associated Flares in Hepatitis D Infection. J Viral Hepat. 2025 Apr;32(4):e70022. doi: 10.1111/jvh.70022.
- Derived from this study: PubMed 37787009Anastasiou OE, Caruntu FA, Curescu MG, Yalcin K, Akarca US, Gurel S, Zeuzem S, Erhardt A, Luth S, Papatheodoridis GV, Keskin O, Port K, Radu M, Celen MK, Idilman R, Heidrich B, Mederacke I, von der Leyen H, Kahlhofer J, von Karpowitz M, Hardtke S, Cornberg M, Yurdaydin C, Wedemeyer H. Five-year follow-up of 96 weeks peginterferon plus tenofovir disoproxil fumarate in hepatitis D. Liver Int. 2024 Jan;44(1):139-147. doi: 10.1111/liv.15745. Epub 2023 Oct 3.
- Derived from this study: PubMed 30833068Wedemeyer H, Yurdaydin C, Hardtke S, Caruntu FA, Curescu MG, Yalcin K, Akarca US, Gurel S, Zeuzem S, Erhardt A, Luth S, Papatheodoridis GV, Keskin O, Port K, Radu M, Celen MK, Idilman R, Weber K, Stift J, Wittkop U, Heidrich B, Mederacke I, von der Leyen H, Dienes HP, Cornberg M, Koch A, Manns MP; HIDIT-II study team. Peginterferon alfa-2a plus tenofovir disoproxil fumarate for hepatitis D (HIDIT-II): a randomised, placebo controlled, phase 2 trial. Lancet Infect Dis. 2019 Mar;19(3):275-286. doi: 10.1016/S1473-3099(18)30663-7.
- Derived from this study: PubMed 30516520Bremer B, Anastasiou OE, Ciesek S, Wedemeyer H. Automated nucleic acid isolation methods for HDV viral load quantification can lead to viral load underestimation. Antivir Ther. 2019;24(2):117-123. doi: 10.3851/IMP3281.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael P. Manns, Prof. Dr. study director
Hannover Medical School
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PEG-IFN alfa-2a, Tenofovir in people with Hepatitis D, run by HepNet Study House, German Liverfoundation at 10 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Germany, Romania, Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Negativation of HDV-RNA at the end of therapy (time frame: week 96). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00932971, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2018.