Liver DiseasePhase 2NCT03600714
Treatment of Chronic Delta Hepatitis With Lonafarnib, Ritonavir and Lambda Interferon
A Phase 2 study testing Peg-interferon lambda, Lonafarnib and Ritonavir in people with Liver Disease and Hepatitis D, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
Background: Infection with hepatitis D virus leads to a chronic liver disease with no effective treatment. Lonafarnib has improved hepatitis D virus levels in blood, but the medication still needs more research. Ritonavir makes other drugs more effective and is used with lonafarnib to make it more effective. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Disease, Hepatitis D
- What is being tested?
- Peg-interferon lambda, Lonafarnib and Ritonavir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2018to 11 Aug 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Age 18 years or above, male or female.
- Presence of anti-HDV in serum.
- Presence of quantifiable HDV RNA in serum at three time pre-treatment points with a mean HDV RNA level >2 log10 above the lower limit of quantification (LLOQ) of the HDV RNA assay.
- Demonstration of chronicity as evidenced by the presence of HDV RNA in serum for >/= 6 months, or presence of Anti-HDV antibody >/= 6months.
Who cannot join
- Decompensated liver disease, defined by bilirubin >4mg/dL, albumin <3.0 gm/dL, prothrombin time >2 sec prolonged, or history of bleeding esophageal varices, ascites or hepatic encephalopathy. Laboratory abnormalities that are not thought to be due to liver disease may not necessarily require exclusion. Patients with ALT levels greater than 1000 U/L (>25 times ULN) will not be enrolled but may be followed until three determinations are below this level. Patients with an absolute neutrophil count <1000/dL and platelets <75,000/dL will be excluded from the study as well.
- Pregnancy, active breast-feeding, or inability to practice adequate contraception, in women of childbearing potential or in partners of such women. Adequate contraception is defined as vasectomy in male sexual partners of female participants, tubal ligation in women, or use of two contraceptive methods such as condoms and spermicide combination with an intrauterine device or Depo-Provera, or Norplant.
- Significant systemic or major illnesses other than liver disease, including, but not limited to, congestive heart failure, renal failure (eGFR <50 ml/min), organ transplantation, serious psychiatric disease or depression (only if felt to be at high risk by the NIH psychiatric consultation service), or active coronary artery disease.
- Systemic immunosuppressive therapy within the previous 2 months before enrollment.
- Evidence of another form of liver disease in addition to viral hepatitis (for example autoimmune liver disease, primary biliary cirrhosis, primary sclerosing cholangitis, Wilson disease, alcoholic liver disease, ongoing drug induced liver disease, nonalcoholic steatohepatitis (but not steatosis), hemochromatosis, or alpha-1-antitrypsin deficiency).
- Active substance abuse, such as alcohol, inhaled or injection drugs within the previous year.
Show all 20Show fewer
- Evidence of hepatocellular carcinoma. This will be determined on the basis of imaging with ultrasound/ CT scan or MRI performed a maximum of 6 months prior to enrollment. Elevated alpha fetoprotein (AFP) levels will be evaluated clinically and further imaging may be performed if felt necessary.
- Evidence of concurrent hepatitis C infection with positive serum hepatitis C virus (HCV) RNA.
- Any experimental therapy or pegylated interferon therapy within 6 months prior to enrollment.
- Active, serious autoimmune disease such as systemic lupus erythematosus, ulcerative colitis, Crohn s disease or rheumatoid arthritis, that is in the opinion of the investigators might be exacerbated by therapy with lambda interferon. This will be evaluated at baseline and during follow-up laboratory testing (including blood and urine studies) in addition to described symptoms at each outpatient visit.
- Diagnosis of malignancy in the five years prior to the enrollment with exception granted to superficial dermatologic malignancies.
- Evidence of HIV co-infection; HIV 1/2 antibody positivity on serum testing.
- Concurrent usage of statins as these drugs inhibits mevalonate synthesis, which reduces protein prenylation.
- Concurrent usage of moderate and strong CYTOCHROME P-450 CYP3A (CYP3A) inhibitors and inducers.
- Concurrent usage of alpha 1 adrenoreceptor antagonist, antiarrhythmic, pimozide, sildenafil, sedative and hypnotics, ergot and St. John s Wort due to possible effect of ritonavir on hepatic metabolism of these drugs resulting in potentially life-threatening side effects.
- Clinically significant baseline EKG abnormalities such as corrected QT (QTc) interval >450 ms and/or prolonged PR interval.
- Uncontrolled elevated triglycerides (>500 mg/dL). Patients on lipid lowering therapy other than statins will be eligible for this study.
- History of pancreatitis from causes other than gallstone pancreatitis. Subjects with a baseline amylase and/or lipase level >3 ULN will be excluded from the study.
- Inability to understand or sign informed consent.
- Any other condition, which in the opinion of the investigators would impede the patient s participation or compliance in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Background:
Infection with hepatitis D virus leads to a chronic liver disease with no effective treatment. Lonafarnib has improved hepatitis D virus levels in blood, but the medication still needs more research. Ritonavir makes other drugs more effective and is used with lonafarnib to make it more effective. Lambda interferon stimulates the body s response to viruses. Researchers want to see if combining these drugs fights hepatitis D and helps the liver.
Read more
Objectives:
To see if combining lonafarnib, ritonavir, and lambda interferon is safe and effective to treat chronic hepatitis D infection.
Eligibility:
Adults at least 18 years old with chronic hepatitis D infection
Design:
Participants will be screened with a physical exam, medical history, and blood and urine tests.
Throughout the study, all participants will:
- Follow rules for medicine, food, and contraception
- Take hepatitis B medicine
- Have weight checked
- Have routine blood and urine tests
- Give stool samples
- Female participants will have pregnancy tests.
Participants will have 3 visits before treatment. They will repeat screening tests and have a heart test and liver scan.
Participants will have a 5-day inpatient stay. They will:
- Baseline blood and urine tests
- Have eye tests
- Answer health questions
- Have a liver sample taken and liver blood pressure measured. Participants will be sedated.
- Have reproductive tests
- Start the study drugs and have blood draws
Over 24 weeks of treatment, participants will:
-Take 2 study drugs by mouth every day and 1 as a weekly injection
Read the detailed description
Chronic delta hepatitis is a serious form of chronic liver disease caused by infection with the hepatitis D virus (HDV), a small RNA virus that requires farnesylation of its major structural protein (HDV antigen) for replication. Based on previous and ongoing clinical trials demonstrating effectiveness against HDV, we propose to treat 26 adult patients with chronic delta hepatitis using the combination of the farnesyltransferase inhibitor (FTI) lonafarnib (LNF), the protease inhibitor ritonavir (RTV) and peginterferon lambda-1a(lambda). In this phase 2a open label study, the safety and antiviral effects of triple therapy with LNF, RTV and lambda for a period of 6 months. After dosing, all patients will be monitored for 24 weeks off therapy. Nucleos(t)ide analogue therapy will be instituted/continued during this study to prevent the possibility of hepatitis B virus (HBV) reactivation/flare for the duration of participation in this clinical trial. Patients with quantifiable HDV RNA in serum will be enrolled. At each clinic visit, patients will be questioned about side effects, symptoms and quality of life, undergo focused physical examination, and have blood drawn for complete blood counts, HDV RNA, and routine liver tests (including alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, direct and total bilirubin, and albumin). At the end of the treatment, patients will be admitted to the clinical center and will undergo repeat liver biopsy and hepatic venous pressure gradient (HVPG) measurements, repeat physical examination, assessment of symptoms (using a symptom scale questionnaire), complete blood counts, routine liver tests, and hepatitis B and D viral markers. The primary therapeutic endpoint will be a decline of HDV RNA viral titer of 2 logs at the end of therapy. The primary safety endpoint will be the ability to tolerate the drugs at the prescribed dose for the full course of therapy. This clinical trial is designed as a phase 2a study assessing the antiviral activity, safety and tolerance of fixed doses of lonafarnib, ritonavir and peginterferon lambda.
- Conditions
- Liver Disease, Hepatitis D
- Being tested
- Peg-interferon lambda, Lonafarnib, Ritonavir
- Keywords
- Hepatitis D, Hepatitis D Virus, Cirrhosis
- Medical subject headings
- Liver Diseases, Hepatitis D, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peg-interferon lambdaDrug
Peg-interferon Lambda is a covalent conjugate of human recombinant non- pegylated interferon (IFN) lambda and a 20-kDa linear pegylated (PEG) chain.
LonafarnibDrug
Oral prenylation inhibitor
RitonavirDrug
Booster of lonafarnib action
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Treatment with Lonafarnib, Ritonavir, and Peginterferon lambda Receives: Drug: Peg-interferon lambda; Drug: Lonafarnib; Drug: Ritonavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Decline of Hepatitis D Virus (HDV) RNA Viral Titer of >2 Logs
Decline of HDV RNA viral titer of >2 logs from baseline at 24 weeks of therapy
Measured: Baseline and 24 weeks
Number of Participants Who Discontinue Medication
Discontinuation of the medication before 24 weeks by the clinical team or patient will be considered a failure to tolerate the medicine.
Measured: 24 weeks
Secondary outcomes (10)
Number of Participants With Sustained Virologic Response
Undetectable HDV RNA at both 12 and 24 weeks post treatment follow-up visits
Measured: 12 and 24 weeks after completing therapy
Number of Participants With Reduction in Histologic Inflammatory Scores (Modified HAI)
Reduction in histologic inflammatory scores (modified HAI) by at least two points with no progression in histologic fibrosis (Ishak) at week 24 post-treatment follow-up.
Measured: End of treatment and 24 weeks after completing therapy.
Number of Participants With Normalization of Serum ALT
Normalization of serum ALT (ALT <20 in females and ALT <31 in males) at the end of therapy, at week 12 of posttherapy follow-up and at week 24 of post-therapy follow-up, OR reduction in serum ALT by >50% of baseline at week 12 of post therapy follow up and week 24 of post therapy follow up.
Measured: End of therapy, and 12 and 24 weeks after completing therapy
Number of Participants With Reduction of Hepatic Venous Pressure Gradient (HVPG)
Reduction in hepatic venous pressure gradient (HVPG) measurements by >25% of baseline OR normalization of HVPG (<5 mm Hg) at 24 weeks after completing therapy
Measured: Baseline and 24 weeks after completing therapy
Number of Participants With Reduction in Fibroscan Transient Elastography Values
Reduction in Fibroscan transient elastography values by >25% of baseline at end of therapy.
Measured: Baseline and 24 weeks
Number of Participants With Loss of HBsAg at Week 24
Loss of HBsAg from the serum at week 24
Measured: Week 24
Number of Participants With Loss of HBsAg at Week 12 Weeks After Completing Therapy
Loss of HBsAg from the serum at 12 weeks after completing therapy
Measured: 12 weeks after completing therapy
Number of Participants With Loss of HBsAg at 24 Weeks After Completing Therapy
Loss of HBsAg from the serum at 24 weeks after completing therapy
Measured: 24 weeks after completing therapy
Change in Quantitative Log HBsAg Levels From Baseline to Week 24
Change in quantitative log HBsAg levels at from baseline to week 24
Measured: Baseline and week 24
Change in Quantitative Log HBsAg Levels From Baseline 24 Weeks After Completing Therapy
Change in quantitative log HBsAg levels at from baseline to 24 weeks after completing therapy
Measured: Baseline and 24 weeks after completing therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start1 Aug 2018
- Primary completion5 Feb 2020
- Study completion11 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Liver DiseaseStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Christopher Koh, M.D., Principal investigator, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03600714
- Sponsor's protocol ID
- 180123
- Other IDs
- 18-DK-0123
- Status last verified
- Dec 2021
- First submitted
- 25 Jul 2018
- Last updated
- 14 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Chronic Delta Hepatitis With Lonafarnib, Ritonavir and Lambda Interferon
- ClinicalTrials.gov ID
- NCT03600714
- Acronym / sponsor ID
- 180123
- Conditions
- Liver Disease, Hepatitis D
- Keywords
- Hepatitis D, Hepatitis D Virus, Cirrhosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 5 Feb 2020 (actual)
- Study completion
- 11 Aug 2020 (actual)
- First posted
- 26 Jul 2018 (actual)
- Results
- Posted 1 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
Infection with hepatitis D virus leads to a chronic liver disease with no effective treatment. Lonafarnib has improved hepatitis D virus levels in blood, but the medication still needs more research. Ritonavir makes other drugs more effective and is used with lonafarnib to make it more effective. Lambda interferon stimulates the body s response to viruses. Researchers want to see if combining these drugs fights hepatitis D and helps the liver.
Objectives:
To see if combining lonafarnib, ritonavir, and lambda interferon is safe and effective to treat chronic hepatitis D infection.
Eligibility:
Adults at least 18 years old with chronic hepatitis D infection
Design:
Participants will be screened with a physical exam, medical history, and blood and urine tests.
Throughout the study, all participants will:
- Follow rules for medicine, food, and contraception
- Take hepatitis B medicine
- Have weight checked
- Have routine blood and urine tests
- Give stool samples
- Female participants will have pregnancy tests.
Participants will have 3 visits before treatment. They will repeat screening tests and have a heart test and liver scan.
Participants will have a 5-day inpatient stay. They will:
- Baseline blood and urine tests
- Have eye tests
- Answer health questions
- Have a liver sample taken and liver blood pressure measured. Participants will be sedated.
- Have reproductive tests
- Start the study drugs and have blood draws
Over 24 weeks of treatment, participants will:
-Take 2 study drugs by mouth every day and 1 as a weekly injection
Detailed description
Chronic delta hepatitis is a serious form of chronic liver disease caused by infection with the hepatitis D virus (HDV), a small RNA virus that requires farnesylation of its major structural protein (HDV antigen) for replication. Based on previous and ongoing clinical trials demonstrating effectiveness against HDV, we propose to treat 26 adult patients with chronic delta hepatitis using the combination of the farnesyltransferase inhibitor (FTI) lonafarnib (LNF), the protease inhibitor ritonavir (RTV) and peginterferon lambda-1a(lambda). In this phase 2a open label study, the safety and antiviral effects of triple therapy with LNF, RTV and lambda for a period of 6 months. After dosing, all patients will be monitored for 24 weeks off therapy. Nucleos(t)ide analogue therapy will be instituted/continued during this study to prevent the possibility of hepatitis B virus (HBV) reactivation/flare for the duration of participation in this clinical trial. Patients with quantifiable HDV RNA in serum will be enrolled. At each clinic visit, patients will be questioned about side effects, symptoms and quality of life, undergo focused physical examination, and have blood drawn for complete blood counts, HDV RNA, and routine liver tests (including alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, direct and total bilirubin, and albumin). At the end of the treatment, patients will be admitted to the clinical center and will undergo repeat liver biopsy and hepatic venous pressure gradient (HVPG) measurements, repeat physical examination, assessment of symptoms (using a symptom scale questionnaire), complete blood counts, routine liver tests, and hepatitis B and D viral markers. The primary therapeutic endpoint will be a decline of HDV RNA viral titer of 2 logs at the end of therapy. The primary safety endpoint will be the ability to tolerate the drugs at the prescribed dose for the full course of therapy. This clinical trial is designed as a phase 2a study assessing the antiviral activity, safety and tolerance of fixed doses of lonafarnib, ritonavir and peginterferon lambda.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Peg-interferon lambda, Drug: Lonafarnib, Drug: RitonavirTreatment with Lonafarnib, Ritonavir, and Peginterferon lambda |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years or above, male or female.
- Presence of anti-HDV in serum.
- Presence of quantifiable HDV RNA in serum at three time pre-treatment points with a mean HDV RNA level >2 log10 above the lower limit of quantification (LLOQ) of the HDV RNA assay.
- Demonstration of chronicity as evidenced by the presence of HDV RNA in serum for >/= 6 months, or presence of Anti-HDV antibody >/= 6months.
Key exclusion criteria (20 listed)
- Decompensated liver disease, defined by bilirubin >4mg/dL, albumin <3.0 gm/dL, prothrombin time >2 sec prolonged, or history of bleeding esophageal varices, ascites or hepatic encephalopathy. Laboratory abnormalities that are not thought to be due to liver disease may not necessarily require exclusion. Patients with ALT levels greater than 1000 U/L (>25 times ULN) will not be enrolled but may be followed until three determinations are below this level. Patients with an absolute neutrophil count <1000/dL and platelets <75,000/dL will be excluded from the study as well.
- Pregnancy, active breast-feeding, or inability to practice adequate contraception, in women of childbearing potential or in partners of such women. Adequate contraception is defined as vasectomy in male sexual partners of female participants, tubal ligation in women, or use of two contraceptive methods such as condoms and spermicide combination with an intrauterine device or Depo-Provera, or Norplant.
- Significant systemic or major illnesses other than liver disease, including, but not limited to, congestive heart failure, renal failure (eGFR <50 ml/min), organ transplantation, serious psychiatric disease or depression (only if felt to be at high risk by the NIH psychiatric consultation service), or active coronary artery disease.
- Systemic immunosuppressive therapy within the previous 2 months before enrollment.
- Evidence of another form of liver disease in addition to viral hepatitis (for example autoimmune liver disease, primary biliary cirrhosis, primary sclerosing cholangitis, Wilson disease, alcoholic liver disease, ongoing drug induced liver disease, nonalcoholic steatohepatitis (but not steatosis), hemochromatosis, or alpha-1-antitrypsin deficiency).
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-interferon lambdaPeg-interferon Lambda is a covalent conjugate of human recombinant non- pegylated interferon (IFN) lambda and a 20-kDa linear pegylated (PEG) chain. | Drug | Treatment |
| LonafarnibOral prenylation inhibitor | Drug | Treatment |
| RitonavirBooster of lonafarnib action | Drug | Treatment |
Primary outcome
Number of Participants With Decline of Hepatitis D Virus (HDV) RNA Viral Titer of >2 Logs
Time frame: Baseline and 24 weeks
Decline of HDV RNA viral titer of >2 logs from baseline at 24 weeks of therapy
Number of Participants Who Discontinue Medication
Time frame: 24 weeks
Discontinuation of the medication before 24 weeks by the clinical team or patient will be considered a failure to tolerate the medicine.
10 secondary outcomes
Number of Participants With Sustained Virologic Response
Time frame: 12 and 24 weeks after completing therapy
Number of Participants With Reduction in Histologic Inflammatory Scores (Modified HAI)
Time frame: End of treatment and 24 weeks after completing therapy.
Number of Participants With Normalization of Serum ALT
Time frame: End of therapy, and 12 and 24 weeks after completing therapy
Number of Participants With Reduction of Hepatic Venous Pressure Gradient (HVPG)
Time frame: Baseline and 24 weeks after completing therapy
Number of Participants With Reduction in Fibroscan Transient Elastography Values
Time frame: Baseline and 24 weeks
Number of Participants With Loss of HBsAg at Week 24
Time frame: Week 24
Number of Participants With Loss of HBsAg at Week 12 Weeks After Completing Therapy
Time frame: 12 weeks after completing therapy
Number of Participants With Loss of HBsAg at 24 Weeks After Completing Therapy
Time frame: 24 weeks after completing therapy
Change in Quantitative Log HBsAg Levels From Baseline to Week 24
Time frame: Baseline and week 24
Change in Quantitative Log HBsAg Levels From Baseline 24 Weeks After Completing Therapy
Time frame: Baseline and 24 weeks after completing therapy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- NIH Clinical Center Detailed Web PageLink 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.
Christopher Koh, M.D. principal investigator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Peg-interferon lambda, Lonafarnib and Ritonavir in people with Liver Disease and Hepatitis D, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
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 4 inclusion and 20 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 14 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. 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?
Yes. Results are posted in the registry (first posted 1 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Decline of Hepatitis D Virus (HDV) RNA Viral Titer of >2 Logs (time frame: Baseline and 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Dec 2021.