Sever Aplastic AnaemiaPhase 1NCT05088642
A Trial of Hetrombopag in Healthy and Hepatic Impairment Subjects
A Phase 1 study testing Hetrombopag Olamine Tablet in people with Sever Aplastic Anaemia, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
This is a single-dose, open-label, phase I clinical study evaluating the PK of hetrombopag in subjects with mild hepatic impairment (Child-Pugh Class A), subjects with moderate hepatic impairment (Child-Pugh Class B), as well as age-, weight-, and gender-matched subjects with normal hepatic function. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sever Aplastic Anaemia
- What is being tested?
- Hetrombopag Olamine Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 28 Sep 2020to 4 Dec 2020
- Phase
- Phase 1
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sign the informed consent form before the study and fully understand the study content, process, and possible adverse reactions; able to complete the study as required by the clinical study protocol;
- Subjects (and their partners) are willing to adopt effective contraceptive measures from screening to 6 months after the last study administration. See Appendix 1 for specific contraceptive measures;
- Aged 18-65 years (inclusive), male or female;
- Body mass index (BMI = weight (kg)/height2 (m2)): 18-30 kg/m2 (inclusive);
- For subjects with normal hepatic function: normal or abnormal but not clinically significant laboratory findings (hematology, blood biochemistry, urinalysis, and coagulation function);
- For subjects with normal hepatic function: no history of severe primary disorders involving major organs, including but not limited to the gastrointestinal, respiratory, renal, hepatic, neural, hematological, endocrine, neoplastic, immunological, psychiatric, or cardiovascular and cerebrovascular disorders.
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- Subjects with hepatic insufficiency must also meet the following inclusion criteria:
- Have not received medication within 4 weeks before screening, or have received stable medication for at least 4 weeks for hepatic impairment and/or other concurrent diseases requiring long-term treatment;
- With Child-Pugh Class A or B hepatic insufficiency caused by prior primary liver disorders (except drug-induced liver diseases).
Who cannot join
- Average daily consumption of > 5 cigarettes within 3 months before screening;
- Allergic constitution, or allergy to any component of hetrombopag olamine tablets;
- Average daily alcohol consumption of > 15 g for females (e.g., 145 mL of wine, 497 mL of beer, or 43 mL of low-alcohol liquor) and > 25 g for males (e.g., 290 mL of wine, 994 mL of beer, or 86 mL of low-alcohol liquor) within 3 months before screening;
- History of drug abuse within 3 months before screening;
- Have donated or lost ≥ 400 mL of blood, or have received blood transfusion within 3 months before screening;
- Have undergone major surgery within 6 months before screening, or with incomplete healing of surgical incision;
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- History of deep vein thrombosis or other thromboembolic events, or clinical symptoms suggesting thrombophilia;
- Have received TPO receptor agonists (such as eltrombopag and romiplostim) or TPO within 1 month before screening;
- Have taken Chinese herbal medicines or any drug that affects the PK of hetrombopag within 14 days before study administration (see Appendix 2 for drug-drug interaction evaluation);
- Hypertension [systolic blood pressure (SBP) ≥ 160 mmHg and/or diastolic blood pressure (DBP) ≥ 100 mmHg, confirmed by a re-measurement];
- Female subjects who are in lactation or have a positive serum pregnancy test result at screening or during the study;
- Abnormal and clinically significant 12-lead ECG results (such as tachycardia/bradycardia requiring pharmacological treatment, second- or third-degree atrioventricular block or QTcF interval prolongation (≥ 470 ms for males, ≥ 480 ms for females) (corrected according to Fridericia's formula), or other clinically significant abnormalities assessed by the clinician);
- Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2 calculated using the Modification of Diet in Renal Disease (MDRD) equation;
- Have malignant tumors or history of malignant tumors within 5 years before screening (except treated non-melanoma skin cancer without sign of recurrence and resected cervical intraepithelial neoplasia);
- For subjects with normal hepatic function: have participated in any drug or medical device clinical trials within 3 months before screening; for subjects with hepatic insufficiency: have participated in any drug or medical device clinical trials within 1 month before screening;
- For subjects with normal hepatic function: test positive for hepatitis B surface antigen, hepatitis C antibody or hepatitis C core antigen, HIV antibody, or syphilis antibody in screening;
- Probably undergo surgery or be hospitalized during the study;
- Have consumed alcohol (or positive for breath alcohol test), grapefruit/grapefruit juice, or any food or beverage containing methylxanthine (such as coffee, tea, cola, chocolate, and energy drink), have participated in strenuous physical activities, or have other factors that may affect drug absorption, distribution, metabolism, and excretion within 1 day before study administration;
- Positive for urine drug screening (morphine or marijuana);
- Subjects judged by the investigator as unsuitable for participating in this study.
- Additional exclusion criteria for subjects with hepatic insufficiency (those who meet any of the followings are ineligible):
- History of liver transplant;
- Liver failure, or liver cirrhosis complicated with hepatic encephalopathy, hepatocellular carcinoma, esophageal and gastric varices hemorrhage, and other complications that, in the opinion of the investigator, make subjects unsuitable for participating in this study;
- History of any serious diseases, other than primary liver diseases, or history of disorders and/or clinically significant abnormal laboratory findings that, as judged by the investigator, may affect the results of the study, including but not limited to the history of diseases in the circulatory system, endocrine system, nervous system, digestive system, urinary system or blood, immune, mental and metabolic diseases.
- Positive for HIV antibody screening; a rapid plasma reagin (RPR) test is required for a subject who tests positive for syphilis antibodies, and the subject should be excluded if the RPR result is also positive.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Bethune Hospital of Jilin University
Changchun, Jilin, 130061
About this study
Official title: A Phase I Clinical Study Evaluating the Pharmacokinetics and Safety of Hetrombopag Olamine Tablets in Subjects With Mild Hepatic Impairment (Child-Pugh Class A), Moderate Hepatic Impairment (Child-Pugh Class B), and Normal Hepatic Function
This is a single-dose, open-label, phase I clinical study evaluating the PK of hetrombopag in subjects with mild hepatic impairment (Child-Pugh Class A), subjects with moderate hepatic impairment (Child-Pugh Class B), as well as age-, weight-, and gender-matched subjects with normal hepatic function.
- Conditions
- Sever Aplastic Anaemia
- Being tested
- Hetrombopag Olamine Tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hetrombopag Olamine TabletDrug
Hetrombopag Olamine Tablet
| Study group | Role | What they receive |
|---|---|---|
| Mild hepatic impairment (Child-Pugh Class A) | Experimental | Not described Receives: Drug: Hetrombopag Olamine Tablet |
| Moderate hepatic impairment (Child-Pugh Class B) | Experimental | Not described Receives: Drug: Hetrombopag Olamine Tablet |
| Normal hepatic function | Experimental | Not described Receives: Drug: Hetrombopag Olamine Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak plasma concentration (Cmax)
Measured: 0-120 hours post dose
Area Under the plasma concentration vs time curve (AUC0-120).
Measured: 0-120 hours post dose
Area under the blood concentration vs time curve (AUC0-inf).
Measured: 0-infinity
Secondary outcomes (3)
Time to Reach Maximum Drug Concentration in Plasma After Single Dose (Tmax)
Measured: 0-120 hours post dose
Half-life Associated With the Terminal Slope (t½)
Measured: 0-120 hours post dose
The number of volunteers with adverse events as a measure of safety and tolerability
Measured: up to Day 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2021
- Study start28 Sep 2020
- Primary completion4 Dec 2020
- Study completion4 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sever Aplastic AnaemiaStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05088642
- Sponsor's protocol ID
- SHR8735-109
- Status last verified
- Oct 2021
- First submitted
- 12 Oct 2021
- Last updated
- 22 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study Evaluating the Pharmacokinetics and Safety of Hetrombopag Olamine Tablets in Subjects With Mild Hepatic Impairment (Child-Pugh Class A), Moderate Hepatic Impairment (Child-Pugh Class B), and Normal Hepatic Function
- ClinicalTrials.gov ID
- NCT05088642
- Acronym / sponsor ID
- SHR8735-109
- Conditions
- Sever Aplastic Anaemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Sep 2020 (actual)
- Primary completion
- 4 Dec 2020 (actual)
- Study completion
- 4 Dec 2020 (actual)
- First posted
- 22 Oct 2021 (actual)
- 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.
This is a single-dose, open-label, phase I clinical study evaluating the PK of hetrombopag in subjects with mild hepatic impairment (Child-Pugh Class A), subjects with moderate hepatic impairment (Child-Pugh Class B), as well as age-, weight-, and gender-matched subjects with normal hepatic function.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mild hepatic impairment (Child-Pugh Class A) | Experimental | Drug: Hetrombopag Olamine Tablet |
| Moderate hepatic impairment (Child-Pugh Class B) | Experimental | Drug: Hetrombopag Olamine Tablet |
| Normal hepatic function | Experimental | Drug: Hetrombopag Olamine Tablet |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Sign the informed consent form before the study and fully understand the study content, process, and possible adverse reactions; able to complete the study as required by the clinical study protocol;
- Subjects (and their partners) are willing to adopt effective contraceptive measures from screening to 6 months after the last study administration. See Appendix 1 for specific contraceptive measures;
- Aged 18-65 years (inclusive), male or female;
- Body mass index (BMI = weight (kg)/height2 (m2)): 18-30 kg/m2 (inclusive);
- For subjects with normal hepatic function: normal or abnormal but not clinically significant laboratory findings (hematology, blood biochemistry, urinalysis, and coagulation function);
Key exclusion criteria (25 listed)
- Average daily consumption of > 5 cigarettes within 3 months before screening;
- Allergic constitution, or allergy to any component of hetrombopag olamine tablets;
- Average daily alcohol consumption of > 15 g for females (e.g., 145 mL of wine, 497 mL of beer, or 43 mL of low-alcohol liquor) and > 25 g for males (e.g., 290 mL of wine, 994 mL of beer, or 86 mL of low-alcohol liquor) within 3 months before screening;
- History of drug abuse within 3 months before screening;
- Have donated or lost ≥ 400 mL of blood, or have received blood transfusion within 3 months before screening;
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 |
|---|---|---|
| Hetrombopag Olamine TabletHetrombopag Olamine Tablet | Drug | Mild hepatic impairment (Child-Pugh Class A), Moderate hepatic impairment (Child-Pugh Class B), Normal hepatic function |
Primary outcome
Peak plasma concentration (Cmax)
Time frame: 0-120 hours post dose
Area Under the plasma concentration vs time curve (AUC0-120).
Time frame: 0-120 hours post dose
Area under the blood concentration vs time curve (AUC0-inf).
Time frame: 0-infinity
3 secondary outcomes
Time to Reach Maximum Drug Concentration in Plasma After Single Dose (Tmax)
Time frame: 0-120 hours post dose
Half-life Associated With the Terminal Slope (t½)
Time frame: 0-120 hours post dose
The number of volunteers with adverse events as a measure of safety and tolerability
Time frame: up to Day 6
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 22 Oct 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Sever Aplastic Anaemia
RecruitingPhase 2
Dose-attenuated IST and Hetrombopag in Elderly (≥65 Years) Patients With Severe Aplastic Anemia
Sever Aplastic Anaemia, Elderly (People Aged 65 or More)
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Hetrombopag Olamine Tablet in people with Sever Aplastic Anaemia, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
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 9 inclusion and 25 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 22 Oct 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 China. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Peak plasma concentration (Cmax) (time frame: 0-120 hours post dose). The study lists 3 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 22 Oct 2021.