A Phase 1 interventional study of Zanubrutinib in Hepatic Insufficiency & Healthy Subjects, sponsored by BeiGene. Completed at 2 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-04-24.
Sponsored by BeiGene · Phase 1, Interventional, and Treatment
Among 52 studies in Hepatic Insufficiency with a site in United States — 3 open to participants now, 4 under way, none of them phase 3. Hepatic Insufficiency · United States.
Among the 52 studies in Hepatic Insufficiency with a site in United States, this one is the 21st largest by enrollment of the 48 interventional ones that give a count, is one of 2 that started in 2018, is one of 42 in phase 1, and was the 29th registered.
113 studies on the registry are indexed under Hepatic Insufficiency; 15 are open to participants now.
Browse Hepatic Insufficiency studies →3 of the 52 studies in Hepatic Insufficiency with a site in United States are open now. Recruiting first, the newest first:
Pfizer · Sites in United States
Ages 18+ · Healthy volunteers
Incyte Corporation · Sites in United States
Ages 18–80
Eli Lilly and Company · Sites in United States, Hungary
Ages 18–85 · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 9 Hepatic Insufficiency studies recruiting now, 3 set no upper age limit and 3 stop at 75 or younger; 1 takes children under 18; 4 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
52 studies; the count open now beside each. This study's row is marked.
First in 2001; this study’s year is marked. 2 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 29 is close to the median of 29 across 100 interventional studies indexed under Hepatic Insufficiency.
Median enrollment 28 across the 48 interventional studies, 28 across the 3 observational. Of the 47 that completed or were terminated, 16 (34%) have results posted.
This tab as a report to print or save as PDF → With an account.
47 of 52 have an industry lead sponsor. The 10 most frequent:
BeiGene is the lead sponsor of 125 studies on the registry; 2 are open to participants now.
Of its 55 completed or terminated interventional studies of FDA-regulated products, 32 (58%) have results posted.
BeOne Medicines has 1 study filed under Hepatic Insufficiency — fewer than ten, so there is no comparison to draw.
3 of the studies in Hepatic Insufficiency with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07401862Eli Lilly and CompanyA Study of Eloralintide (LY3841136) in Participants With Different Levels of Liver Damage and in Participants With Healthy Livers. | 2027-03 |
| NCT07559474Incyte CorporationA Study to Assess the Safety and Pharmacokinetics of INCB123667 When Administered Orally to Adult Participants With Moderate or Severe Hepatic Impairment | 2027-04-13 |
| NCT07677358PfizerA Study to Learn How the Study Medicine Called Atirmociclib is Handled by the Body in People With Normal Liver Function and Different Levels of Liver Disease | 2027-08-14 |
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Among the 52 studies in Hepatic Insufficiency with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
This study is designed to evaluate the safety and pharmacokinetics of zanubrutinib in subjects with impaired liver function in comparison with healthy subjects
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Additional Inclusion Criteria for Healthy Subjects Only:
Additional Inclusion Criteria for Hepatic Impaired Subjects Only:
Exclusion Criteria:
Additional Exclusion Criteria for Hepatic Impaired Subjects Only:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants with normal hepatic function will be administered a single oral dose of Zanubrutinib (80 mg).
Drug: Zanubrutinib
Participants with mild hepatic impairment (Child-Pugh Class A, score of 5 to 6, inclusive) will be administered a single dose of Zanubrutinib (80 mg).
Drug: Zanubrutinib
Participants with moderate hepatic impairment (Child-Pugh Class B, score of 7 to 9, inclusive) will be administered a single dose of Zanubrutinib (80 mg).
Drug: Zanubrutinib
Participants with severe hepatic impairment (Child-Pugh Class C, score of 10 to 15, inclusive) will be administered a single dose of Zanubrutinib (80 mg).
Drug: Zanubrutinib
A single oral dose of 80 mg Zanubrutinib will be administered.
Plasma concentration of Zanubrutinib (BGB-3111) to evaluate protocol specified PK parameters
Plasma concentration of Zanubrutinib (BGB-3111) to evaluate Area Under the Plasma Concentration-Time Curve (AUC) of Zanubrutinib
Time frame: Days 1, 2 & 3
Plasma concentration of Zanubrutinib (BGB-3111) to evaluate protocol specified PK parameters
Plasma concentration of Zanubrutinib (BGB-3111) to evaluate Maximum Observed Plasma Concentration (Cmax) of Zanubrutinib
Time frame: Days 1, 2 & 3
Treatment-Emergent Adverse Events (AE)
Percentage of Participants with Treatment-Emergent Adverse Events (AE)
Time frame: up to Day 17
Plan to share: No
Ran from May 2018 to primary completion in Oct 2018, 4 months.
Of 38 industry-sponsored phase 1 interventional studies under Hepatic Insufficiency, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 17. This study's 4 months is below that.
Counting every sponsor, half of 41 studies reached it within 8 months; a quarter within 5 and three quarters within 17.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Zanubrutinib