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Protocol Details

Treatment of Chronic Delta Hepatitis with Lonafarnib and Ritonavir

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

15-DK-0170

Sponsoring Institute

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Recruitment Detail

Type: Completed Study; data analyses ongoing
Gender: Male & Female
Min Age: 18
Max Age: 99

Referral Letter Required

No

Population Exclusion(s)

Pregnant Women and Fetuses;
Children

Special Instructions

Currently Not Provided

Keywords

Delta Hepatitis;
Hepatitis D;
Liver Disease;
Hepatitis B Virus;
Chronic Hepatitis B

Recruitment Keyword(s)

None

Condition(s)

Hepatitis D

Investigational Drug(s)

Lonafarnib
Ritonavir

Investigational Device(s)

None

Intervention(s)

Drug: Lonafarnib
Drug: Ritonavir
Other: Placebo

Supporting Site

National Institute of Diabetes and Digestive and Kidney Diseases

Background:

- Chronic hepatitis D is a liver disease caused by the hepatitis D virus (HDV). It can be severe and progressive. Most people with hepatitis D will develop scarring and damage to the liver. There is no FDA approved drug to treat chronic hepatitis D. Researchers want to know if the drugs lonafarnib and ritonavir can help people with chronic hepatitis D.

Objective:

- To find out if treatment of hepatitis D with lonafarnib and ritonavir is safe and effective.

Eligibility:

- People 18 years of age and older with chronic hepatitis D. They must not have HIV or other major illnesses.

Design:

- Participants will be screened with medical history, physical exams, and blood tests.

- Participants will have 24 weeks of treatment. They will then have 24 weeks of follow-up.

- Participants will be in 1 of 6 treatment groups. Those in each group will receive different doses of the study drugs. Some groups will start with placebo but will receive treatment after 3 months of placebo.

- Participants will also take drugs to treat hepatitis B.

- Participants will have many visits. These will include:

- One three-day stay at the Clinical Center

- Physical exams

- EKG: small sticky patches will be put on the chest, arms, and legs to trace heart rhythm

- Ultrasounds of the abdomen

- Urine and blood tests

- Stool samples

- Eye exams

- Evaluations by a reproductive endocrinologist (women) or urologist (men). Men may provide a sperm sample (optional).

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Eligibility

INCLUSION CRITERIA:

1. Age 18 years or above, male or female.

2. Serum alanine or aspartate aminotransferase (ALT or AST) activities above the upper limit of normal (ALT greater than or equal to 20 or AST greater than or equal to 20 U/L in females and ALT greater than or equal to 30 or AST greater than or equal to 30 U/L in males) on an average of three determinations taken during the previous 6 months at the NIH clinical center. The mean of the three determinations will be defined as baseline levels.

3. Presence of anti-HDV in serum.

4. Presence of quantifiable HDV RNA in serum.

EXCLUSION CRITERIA:

1. 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.

2. Pregnancy, active breast-feeding, or inability to practice adequate contraception, in women of childbearing potential or in spouses of such women. Adequate contraception is defined as vasectomy in men, tubal ligation in women, or use of two barrier methods such as condoms and spermicide combination, birth control pills, an intrauterine device, Depo-Provera, or Norplant. In total, the participant and their partner must utilize two forms of contraception and one method must include a barrier method.

3. 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), and active coronary artery disease.

4. Systemic immunosuppressive therapy within the previous 2 months.

5. 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, nonalcoholic steatohepatitis (but not steatosis), hemochromatosis, or alpha-1-antitrypsin deficiency).

6. Active substance abuse, such as alcohol, inhaled or injection drugs within the previous year.

7. Evidence of hepatocellular carcinoma.

8. Evidence of concurrent hepatitis C infection with positive serum hepatitis c virus (HCV) RNA.

9. Any experimental therapy or pegylated interferon therapy within 6 months prior to enrollment.

10. Diagnosis of malignancy in the five years prior to the enrollment with exception granted to superficial dermatologic malignancies.

11. Evidence of HIV co-infection; HIV 1/2 viral RNA or antigen on serum testing.

12. Concurrent usage of statins as these drugs inhibits mevalonate synthesis, which reduces protein prenylation.

13. Concurrent usage of moderate and strong cytochrome p450, family 3, subfamily A (CYP3A) inhibitors and inducers.

14. Use of any prescription, nonprescription or natural medicine (herbal) medications unless the use of medication is medically necessary with appropriate monitoring.

15. 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.

16. Clinically significant baseline EKG abnormalities.

17. Uncontrolled elevated triglycerides.

18. History of pancreatitis as a result of hypertriglyceridemia.

19. Inability to understand or sign informed consent.

20. Any other condition, which in the opinion of the investigators would impede the patient s participation or compliance in the study.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Theo Heller, M.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)



Christopher Koh, M.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
BG 10-CRC RM 5-2740
10 CENTER DR
BETHESDA MD 20814
(301) 443-9402
kohchris@mail.nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT02511431

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