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A Phase IV multicenter, observational study in Chronic Immune Thrombocytopenia patients on Eltrombopag treatment in emerging markets

A Phase IV multicenter, observational study in Chronic Immune Thrombocytopenia patients on Eltrombopag treatment in emerging markets

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900021755
Enrollment
Unknown
Registered
2019-03-08
Start date
2019-04-30
Completion date
Unknown
Last updated
2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Immune Thrombocytopenia

Interventions

Single Arm:eltrombopag treatment

Sponsors

Shanghai Sixth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Main Inclusion criteria: 1. Patients diagnosed with immune thrombocytopenia and eligible for Revolade [Turkey: eltrombopag] treatment according to the market authorization in the country and the investigators judgement; 2. cITP patients startingon eltrombopag treatment (patients who started treatment in the current treatment cycle up to 12 weeks prior to study enrollment are also eligible);Previous discontinued treatment cycles of eltrombopag are permitted as long as the time period between the last dose in the previous cycle and the first dose within the CITE study-relevant course is at least 12 weeks; 3. Prior treatment with romiplostim is allowed; 4. Male or female, adults = 18 years; 5. Written informed consent.

Exclusion criteria

Exclusion criteria: Main Exclusion Criteria: 1. Any contraindication listed in the local market authorization/SmPC; 2. Patients with active alcohol or drug addiction that would interfere with their ability; 3. According to the investigators opinion, the patient is an unlikely candidate to obtain longterm follow-up information for any reasons such as unavailability or severe concomitant illnesses; 4. Patients participating in any interventional clinical trial at start of this clinical study; 5. For the indication of ITP also non-interventional studies other than CITE are excluded; 6. No pediatric ITP patients (<18 years) will be included into this NIS; 7. Other indications for eltrombopag such as for patients with chronic hepatitis C virus (HCV) infection for the treatment of thrombocytopenia, or Severe Aplastic Anemia (SAA) are not in scope and will not be enrolled in this NIS.

Design outcomes

Primary

MeasureTime frame
Treatment duration and adherence;Efficacy (hematological and clinical);

Secondary

MeasureTime frame
Treatment algorithm in cITP and Utilization;Quality of life: fatigue;Safety and tolerability;

Countries

China

Contacts

Public ContactChunkang Chang

The Sixth People's Hospital of Shanghai

changchunkang@sina.com+86 18930177640

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026