150 Participants NeededMy employer runs this trial

Hetrombopag Olamine for Low Platelet Count

Recruiting at 6 trial locations
JX
Overseen ByJunye Xiong
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called Hetrombopag Olamine for individuals with low platelet counts due to chemotherapy. The goal is to determine if this treatment is safe and more effective than a placebo (a pill with no medicine) for cancer patients undergoing certain types of chemotherapy. The trial will compare the effects of Hetrombopag Olamine to a placebo across different groups. Individuals with solid tumors, such as lung or breast cancer, who experience low platelet counts from their current chemotherapy, might be suitable candidates for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking advancements in cancer treatment.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that Hetrombopag Olamine is likely to be safe for humans?

Research has shown that hetrombopag olamine is generally safe for people. In earlier studies, most patients handled the treatment well. Serious side effects occurred in only about 5.4% of patients, including a drop in platelet counts and gum bleeding, but such events were uncommon.

Common side effects were mild, such as colds, which appeared in 57.9% of patients compared to 45.2% in those who took a placebo. The treatment has also increased platelet counts, which is important for patients with low levels.

This treatment has been tested in various clinical settings, suggesting it is safe for people with similar conditions. So far, the evidence supports that hetrombopag olamine is generally well-tolerated and safe to use.12345

Why do researchers think this study treatment might be promising?

Researchers are excited about Hetrombopag Olamine because it offers a novel approach to treating low platelet count. Unlike standard treatments like corticosteroids or immunosuppressants, Hetrombopag Olamine is designed to directly stimulate the production of platelets through a new mechanism. This could potentially lead to more efficient and targeted treatment, reducing the need for broad-spectrum therapies that often come with significant side effects. Additionally, its potential to be more effective in a shorter timeframe could greatly improve the quality of life for patients dealing with this condition.

What evidence suggests that Hetrombopag Olamine might be an effective treatment for low platelet count?

Research has shown that Hetrombopag Olamine can increase platelet counts in people with immune thrombocytopenia, a condition where the immune system mistakenly attacks platelets. In studies, patients taking Hetrombopag had higher platelet levels than those taking a placebo, which contains no active medicine. Specifically, one study found that 43.9% of patients treated with Hetrombopag experienced lasting improvement, while none in the placebo group did. The treatment also lowered the risk of bleeding and reduced the need for other treatments. This trial compares Hetrombopag Olamine with a placebo to further evaluate its effectiveness in managing low platelet counts caused by chemotherapy.13567

Are You a Good Fit for This Trial?

This trial is for adults (18+) with solid tumors like lung, breast, or colon cancer who have low platelets due to certain chemotherapy treatments. Participants must be in generally good health, able to care for themselves, and expected to live at least 6 months. People with bleeding problems, blood cancers, serious infections, or other causes of low platelets can't join.

Inclusion Criteria

Signed ICF for voluntary participation in the study and good compliance
Life expectancy ≥6 months
I am fully active or can care for myself with little or no help.
See 3 more

Exclusion Criteria

I have had severe bleeding during the screening period.
I do not have an active or uncontrolled hepatitis B or C infection.
I have a blood cancer.
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Hetrombopag Olamine or placebo to evaluate efficacy and safety in chemotherapy-induced thrombocytopenia

6-8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Hetrombopag Olamine

Trial Overview

The study compares Hetrombopag Olamine tablets versus placebo (inactive pills) in patients whose platelet counts dropped because of chemotherapy. Participants are randomly assigned to receive either the real drug or placebo while continuing their usual cancer treatment.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Part B:Hetrombopag Olamine vs Hetrombopag Olamine PlaceboExperimental Treatment1 Intervention
Group II: Part A: Hetrombopag OlamineExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Jiangsu HengRui Medicine Co., Ltd.

Lead Sponsor

Trials
663
Recruited
102,000+
Founded
1970
Headquarters
Lianyungang, China
Known For
Oncology Innovations
Top Products
Camrelizumab, Rivoceranib (Apatinib)

Citations

Safety and efficacy of hetrombopag in patients with chronic ...

Hetrombopag showed preliminary activity in elevating platelet counts and reducing bleeding in patients with chronic ITP who had received at least one standard ...

Hetrombopag: A promising thrombopoietin receptor ...

The results of this study suggest that lusutrombopag can effectively improve the platelet count in patients with chronic liver disease ...

Hetrombopag Effective in Real-World Patients With ITP

Baseline platelet counts under hetrombopag treatment showed an average 16 × 10⁹/L, and after 2, 8, and 12 weeks, the average platelet counts ...

Hetrombopag: A promising thrombopoietin receptor ...

Hetrombopag, a novel oral TPO-RA developed in China, has demonstrated superior platelet-raising effects compared to Eltrombopag and shows a more favorable ...

A multicenter, randomized phase III trial of hetrombopag - PMC

Hetrombopag was also superior to placebo in achieving a platelet response and in reducing the bleeding risk and use of rescue therapy throughout ...

Safety and efficacy of hetrombopag in patients with chronic ...

In our study, hetrombopag showed preliminary activity in elevating platelet levels and reducing bleeding symptoms in ITP patients who had an insufficient ...

Safety and efficacy of hetrombopag in patients with chronic ...

Conclusions: Hetrombopag showed preliminary activity in elevating platelet counts and reducing bleeding in patients with chronic ITP who had received at least ...